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, 63575-63631 [2016-21589]

Agencies

• Drug Enforcement Administration
• Department of Justice

[Federal Register Volume 81, Number 179 (Thursday, September 15, 2016)]
[Proposed Rules]
[Pages 63575-63631]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2016-21589]



[[Page 63575]]

Vol. 81

Thursday,

No. 179

September 15, 2016

Part II





Department of Justice





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Drug Enforcement Administration





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21 CFR Parts 1300, 1301, 1302, et al.





Revision of Import and Export Requirements for Controlled Substances, 
Listed Chemicals, and Tableting and Encapsulating Machines, Including 
Changes To Implement the International Trade Data System; Revision of 
Reporting Requirements for Domestic Transactions in Listed Chemicals 
and Tableting and Encapsulating Machines; and Technical Amendments; 
Proposed Rule

Federal Register / Vol. 81 , No. 179 / Thursday, September 15, 2016 / 
Proposed Rules

[[Page 63576]]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Parts 1300, 1301, 1302, 1303, 1304, 1308, 1309, 1310, 1312, 
1313, 1314, 1315, 1316, and 1321

[Docket No. DEA-403]
RIN 1117-AB41


Revision of Import and Export Requirements for Controlled 
Substances, Listed Chemicals, and Tableting and Encapsulating Machines, 
Including Changes To Implement the International Trade Data System; 
Revision of Reporting Requirements for Domestic Transactions in Listed 
Chemicals and Tableting and Encapsulating Machines; and Technical 
Amendments

AGENCY: Drug Enforcement Administration, Department of Justice.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Drug Enforcement Administration is proposing to update its 
regulations for the import and export of tableting and encapsulating 
machines, controlled substances, and listed chemicals, and its 
regulations relating to reports required for domestic transactions in 
listed chemicals, gamma-hydroxybutyric acid, and tableting and 
encapsulating machines. In accordance with Executive Order 13563, the 
Drug Enforcement Administration has reviewed its import and export 
regulations and reporting requirements for domestic transactions in 
listed chemicals (and gamma-hydroxybutyric acid) and tableting and 
encapsulating machines, and evaluated them for clarity, consistency, 
continued accuracy, and effectiveness. The proposed amendments clarify 
certain policies and reflect current procedures and technological 
advancements. The amendments also allow for the implementation, as 
applicable to tableting and encapsulating machines, controlled 
substances, and listed chemicals, of the President's Executive Order 
13659 on streamlining the export/import process and requiring the 
government-wide utilization of the International Trade Data System. 
This proposal additionally contains amendments that would implement 
recent changes to the Controlled Substances Import and Export Act 
(CSIEA) for reexportation of controlled substances among members of the 
European Economic Area made by the Improving Regulatory Transparency 
for New Medical Therapies Act. The proposal includes additional 
substantive and technical amendments.

DATES: Electronic comments must be submitted, and written comments must 
be postmarked, on or before October 17, 2016. Commenters should be 
aware that the electronic Federal Docket Management System will not 
accept comments after 11:59 p.m. Eastern Time on the last day of the 
comment period.
    All comments concerning collections of information under the 
Paperwork Reduction Act must be submitted to the Office of Management 
and Budget (OMB) on or before October 17, 2016.

ADDRESSES: To ensure proper handling of comments, please reference 
``Docket No. DEA-403'' on all correspondence, including any 
attachments.
    The Drug Enforcement Administration encourages that all comments be 
submitted through the Federal eRulemaking Portal, which provides the 
ability to type short comments directly into the comment field on the 
Web page or to attach a file for lengthier comments. Please go to 
https://www.regulations.gov and follow the online instructions at that 
site for submitting comments. Upon completion of your submission you 
will receive a Comment Tracking Number for your comment. Please be 
aware that submitted comments are not instantaneously available for 
public view on Regulations.gov. If you have received a Comment Tracking 
Number, your comment has been successfully submitted and there is no 
need to resubmit the same comment. Paper comments that duplicate an 
electronic submission are not necessary and are discouraged. Should you 
wish to mail a paper comment in lieu of an electronic comment, it 
should be sent via regular or express mail to: Drug Enforcement 
Administration, Attention: DEA Federal Register Representative/ODW, 
8701 Morrissette Drive, Springfield, Virginia 22152.
    All comments concerning collections of information under the 
Paperwork Reduction Act must be submitted to the Office of Information 
and Regulatory Affairs, OMB, Attention: Desk Officer for DOJ, 
Washington, DC 20503. Please state that your comment refers to RIN 
1117-AB41/Docket No. DEA-403.

FOR FURTHER INFORMATION CONTACT: Michael J. Lewis, Office of Diversion 
Control, Drug Enforcement Administration; Mailing Address: 8701 
Morrissette Drive, Springfield, Virginia 22152; Telephone: (202) 598-
6812.

SUPPLEMENTARY INFORMATION:

Posting of Public Comments

    Please note that all comments received in response to this docket 
are considered part of the public record. They will, unless reasonable 
cause is given, be made available by the Drug Enforcement 
Administration (DEA or Administration) for public inspection online at 
https://www.regulations.gov. Such information includes personal 
identifying information (such as your name, address, etc.) voluntarily 
submitted by the commenter. The Freedom of Information Act (FOIA) 
applies to all comments received. If you want to submit personal 
identifying information (such as your name, address, etc.) as part of 
your comment, but do not want it to be made publicly available, you 
must include the phrase ``PERSONAL IDENTIFYING INFORMATION'' in the 
first paragraph of your comment. You must also place the personal 
identifying information you do not want made publicly available in the 
first paragraph of your comment and identify what information you want 
redacted.
    If you want to submit confidential business information as part of 
your comment, but do not want it to be made publicly available, you 
must include the phrase ``CONFIDENTIAL BUSINESS INFORMATION'' in the 
first paragraph of your comment. You must also prominently identify 
confidential business information to be redacted within the comment.
    Comments containing personal identifying information and 
confidential business information identified as directed above will 
generally be made publicly available in redacted form. If a comment has 
so much confidential business information or personal identifying 
information that it cannot be effectively redacted, all or part of that 
comment may not be made publicly available. Comments posted to https://www.regulations.gov may include any personal identifying information 
(such as name, address, and phone number) included in the text of your 
electronic submission that is not identified as directed above as 
confidential.
    An electronic copy of this document and supplemental information to 
this proposed rule are available at https://www.regulations.gov for easy 
reference. The DEA specifically solicits written comments regarding the 
DEA's economic analysis of the impact of these proposed changes. The 
DEA requests that commenters provide detailed descriptions in their 
comments of any expected economic impacts, especially to small 
entities. Commenters should

[[Page 63577]]

provide empirical data to illustrate the nature and scope of such 
impact.

Outline

I. Background and Purpose
    A. Legal Authority
    B. Current Import/Export Practices and Regulatory Framework
    1. Import and Export Permits for Controlled Substances
    2. Import and Export Declarations for Controlled Substances
    3. Import and Export Declarations and Notices for Listed 
Chemicals
    4. Import and Export Reports for Tableting and Encapsulating 
Machines; Reports for Domestic Transactions in Listed Chemicals, 
Gamma-Hydroxybutyric Acid, and Tableting and Encapsulating Machines
    5. Transshipments of Controlled Substances
    6. Transshipments of Listed Chemicals
    7. Notifications of International Transactions by Brokers or 
Traders
    C. Purpose of Regulatory Action
II. Discussion of Technical Amendments and Proposed Significant 
Regulatory Changes
    A. Proposed Amendments Directly Associated With Implementation 
of the International Trade Data System
    1. Applications, Notices and Other Filings
    a. Import and Export Permits for Controlled Substances
    b. Import and Export Declarations for Controlled Substances
    c. Import and Export Declarations for Listed Chemicals
    d. Import and Export Reports for Tableting and Encapsulating 
Machines
    e. Transshipments of Controlled Substances
    f. Transshipments of Listed Chemicals
    g. Notifications of International Transactions by Brokers or 
Traders
    2. Security
    3. Miscellaneous
    B. Proposed Amendments Indirectly Associated With Implementation 
of the International Trade Data System
    1. Terminology and Definitions
    2. Part 1302: Labeling and Packaging Requirements for Controlled 
Substances
    3. Part 1304: Records and Reports of Registrants
    4. Part 1308: Schedules of Controlled Substances
    5. Part 1309: Registration of Manufacturers, Distributors, 
Importers and Exporters of List I Chemicals
    6. Part 1310: Records and Reports of Listed Chemicals and 
Certain Machines
    a. Mail Order Reporting for Ephedrine, Pseudoephedrine, 
Phenylpropanolamine, and Gamma-Hydroxybutyric Acid
    b. Listed Chemicals and Tableting and Encapsulating Machines
    7. Part 1312: Importation and Exportation of Controlled 
Substances
    8. Reexportation of Controlled Substances--Including 
Implementation of section 4 of the Improving Regulatory Transparency 
for New Medical Therapies Act
    9. Part 1313: Importation and Exportation of List I and List II 
Chemicals
    10. Part 1316: Administrative Functions, Practices, and 
Procedures
    C. DEA Mailing Addresses
III. Regulatory Analyses

I. Background and Purpose

A. Legal Authority

    The DEA implements and enforces titles II and III of the 
Comprehensive Drug Abuse Prevention and Control Act of 1970, as 
amended. 21 U.S.C. 801-971. Titles II and III are known as the 
``Controlled Substances Act'' and the ``Controlled Substances Import 
and Export Act,'' respectively, and are collectively referred to as the 
``Controlled Substances Act'' or ``CSA'' for the purpose of this 
action. The DEA publishes implementing regulations for these statutes 
in title 21 of the Code of Federal Regulations (CFR), chapter II. The 
CSA and its implementing regulations are designed to prevent, detect, 
and eliminate the diversion of controlled substances and listed 
chemicals into the illicit market while ensuring an adequate supply is 
available for the legitimate medical, scientific, research, and 
industrial needs of the United States. Controlled substances have the 
potential for abuse and dependence and are controlled to protect the 
public health and safety.
    Under the CSA, each controlled substance is classified into one of 
five schedules based upon its potential for abuse, its currently 
accepted medical use in treatment in the United States, and the degree 
of dependence the substance may cause. 21 U.S.C. 812. The initial 
schedules of controlled substances established by Congress are found at 
21 U.S.C. 812(c), and pursuant to 21 U.S.C. 812 (a) and (b), the 
current list of all scheduled substances is published at 21 CFR part 
1308. Controlled substances generally include narcotics, stimulants, 
depressants, and hallucinogens that have a potential for abuse and 
physical and psychological dependence, as well as anabolic steroids. 
Listed chemicals are separately classified based on their use and 
importance to the illicit manufacture of controlled substances (list I 
or list II chemicals). 21 U.S.C. 802 (33)-(35).
    Through the enactment of the CSA and its amendments, Congress has 
established a closed system of distribution making it unlawful to 
handle any controlled substance (manufacture, distribute, reverse 
distribute, dispense, conduct research, engage in narcotic treatment or 
maintenance, import, export, collect, conduct chemical analysis, 
dispose, or possess) or manufacture, distribute, import, or export any 
listed chemical except in a manner authorized by the CSA. See e.g., 
Gonzales v. Raich, 545 U.S. 1, 12-13 (2005) (stating ``The main 
objectives of the CSA were to conquer drug abuse and to control the 
legitimate and illegitimate traffic in controlled substances. Congress 
was particularly concerned with the need to prevent the diversion of 
drugs from legitimate to illicit channels. To effectuate these goals, 
Congress devised a closed regulatory system making it unlawful to 
manufacture, distribute, dispense, or possess any controlled substance 
except in a manner authorized by the CSA. 21 U.S.C. Sec. Sec.  
841(a)(1), 844(a).''); H.R. Rep. No. 91-1444, pt. 1 at 3 (1970) 
(stating: ``Title II: Control and Enforcement.--The bill provides for 
control by the Justice Department of problems related to drug abuse 
through registration of manufacturers, wholesalers, retailers, and all 
others in the legitimate distribution chain, and makes transactions 
outside the legitimate distribution chain illegal.'').
    In order to maintain this closed system of distribution, the CSA 
requires handlers of controlled substances, unless exempt from 
registration, to be registered with the DEA at each principal place of 
business or professional practice where controlled substances are 
manufactured, distributed, or dispensed. 21 U.S.C. 822. The CSA also 
requires persons who manufacture or distribute, or who propose to 
manufacture or distribute, list I chemicals to be registered at each 
principal place of business or professional practice, unless exempt. 21 
U.S.C. 822; 21 CFR 1309.22. A separate registration is also required 
for each principal place of business where controlled substances or 
list I chemicals are imported or exported, unless exempt from 
registration. 21 U.S.C. 958. A ``registrant'' is any person who is 
registered pursuant to either section 303 or section 1008 of the CSA 
(codified at 21 U.S.C. 823 or 958).\1\ 21 CFR 1300.01(b). Registrants 
are permitted to possess controlled substances and list I chemicals as 
authorized by their registration and must comply with the applicable 
requirements associated with their registration. 21 U.S.C. 822 and 958.
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    \1\ Unless otherwise noted, all references to registrant(s) in 
this preamble include persons exempt from DEA registration and 
persons not registered with the DEA as an importer or exporter who 
are authorized to perform importing or exporting activities as a 
coincident activity of their research or chemical analysis 
registration in accordance with 21 CFR 1301.13(e).
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    In contrast, a ``regulated person'' means ``a person who 
manufactures, distributes, imports, or exports a listed

[[Page 63578]]

chemical, a tableting machine, or an encapsulating machine or who acts 
as a broker or trader \2\ for an international transaction \3\ 
involving a listed chemical, a tableting machine, or an encapsulating 
machine.'' 21 U.S.C. 802(38). (Tableting machines and encapsulating 
machines are also commonly known as ``pill presses'' and ``capsule 
fillers'' respectively.) Regulated persons who engage in ``regulated 
transactions,'' defined at 21 U.S.C. 802(39),\4\ are subject to 
specific recordkeeping and reporting requirements pursuant to 21 U.S.C. 
830, 971; 21 CFR part 1310. In addition, a person located in the United 
States who is a broker or trader for an international transaction in a 
listed chemical that is a regulated transaction shall, with respect to 
that transaction, be subject to all of the notification, reporting, 
recordkeeping, and other requirements placed upon exporters of listed 
chemicals. 21 U.S.C. 971(e).
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    \2\ A ``broker'' and ``trader'' are persons that assist in 
arranging an international transaction in a listed chemical by: 
negotiating contracts; serving as an agent or intermediary; or 
bringing together a buyer and seller, a buyer and transporter, or a 
seller and transporter. 21 U.S.C. 802(43).
    \3\ An ``international transaction'' is a transaction that 
involves ``the shipment of a listed chemical across an international 
border (other than a United States border) in which a broker or 
trader located in the United States participates.'' 21 U.S.C. 
802(42).
    \4\ The CSA defines a ``regulated transaction'' as being: (1) 
with certain enumerated exceptions, ``a distribution, receipt, sale, 
importation, or exportation of, or an international transaction 
involving shipment of, a listed chemical, or if the Attorney General 
establishes a threshold amount for a specific listed chemical, a 
threshold amount, including a cumulative threshold amount for 
multiple transactions (as determined by the Attorney General, in 
consultation with the chemical industry and taking into 
consideration the quantities normally used for lawful purposes), of 
a listed chemical;'' and (2) ``a distribution, importation, or 
exportation of a tableting machine or encapsulating machine.'' 21 
U.S.C. 802(39).
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    The CSA grants the Attorney General authority to promulgate rules 
and regulations relating to: the registration of controlled substance 
and list I chemical handlers; control of the manufacture, distribution, 
and dispensing of controlled substances; control of the manufacture and 
distribution of listed chemicals; maintenance and submission of records 
and reports; and for the efficient execution of her statutory 
functions. 21 U.S.C. 821-822, 825, 827-831, 871, 952, 954, 956, 958, 
971. The Attorney General is further authorized by the CSA to 
promulgate rules and regulations relating to the registration and 
control of importers and exporters of controlled substances or listed 
chemicals. 21 U.S.C. 958(f). The Attorney General has delegated these 
authorities to the Administrator of the DEA, who in turn redelegated 
many of these authorities to the Deputy Administrator of the DEA and 
the Deputy Assistant Administrator of the DEA Office of Diversion 
Control. 28 CFR 0.100 et seq.
    Within the DEA, the Office of Diversion Control is the strategic 
focus area that carries out the mandates of the CSA to ensure that 
adequate supplies of controlled substances and listed chemicals are 
available to meet legitimate domestic medical, scientific, industrial, 
and export needs. The Office of Diversion Control carries out the 
mission of the DEA to prevent, detect, and eliminate the diversion of 
these substances into the illicit drug market. Activities in support of 
the Office of Diversion Control and its mission include: Determination 
of program priorities; field management oversight; coordination of 
major investigations; drafting and promulgating regulations; the design 
and proposal of national legislation; advice and leadership on State 
legislation/regulatory initiatives; oversight of the importation and 
exportation of tableting and encapsulating machines, controlled 
substances, and listed chemicals; establishment of national drug 
production quotas; activities related to drug scheduling and compliance 
with international treaty obligations; the design and execution of 
diplomatic missions; computerized monitoring and tracking of the 
distribution of certain controlled substances; planning and allocation 
of program resources; and liaison efforts with industry and their 
representative associations as well as to the DEA's regulatory and law 
enforcement counterparts at the federal, State, tribal, and local 
levels.

B. Current Import/Export Practices and Regulatory Framework

    Under the CSA, a controlled substance, listed chemical, or 
tableting or encapsulating machine is considered imported if it is 
either brought into the customs territory from a place that is outside 
the customs territory but within the United States (e.g., a shipment 
from an insular possession such as Guam into one of the 50 States) or 
brought into the United States from any other place (e.g., a shipment 
from India into one of the 50 States or into an insular possession such 
as American Samoa). 21 U.S.C. 951, 952; see also 21 U.S.C. 802(39), 
830(a). For purposes of the CSA, the ``customs territory of the United 
States'' includes only the 50 States, the District of Columbia, and 
Puerto Rico. 21 U.S.C. 951(a)(2). In contrast, an export of a 
controlled substance, listed chemical, or tableting or encapsulating 
machine occurs when that item is taken out of, or removed from, the 
United States, which, pursuant to the definition at 21 U.S.C. 802(28), 
includes ``all places and waters, continental or insular, subject to 
the jurisdiction of the United States.'' See 21 U.S.C. 802 (38) and 
(39), 830(a), 953(a).
    The DEA regulations are drafted to be consistent with the meaning 
of ``import'' and ``export'' under the CSA, which is broader in scope 
than the meaning of those terms as used in the U.S. Customs and Border 
Protection's (CBP) regulations. The DEA regulations are also drafted to 
take into account the authority of customs officials of U.S. 
territories to enforce the CSA. The CSA and DEA regulations prohibit 
any person from importing or exporting any controlled substance or list 
I chemical unless that person is registered with the DEA (or exempt 
from registration). 21 U.S.C. 957. In addition, these substances may 
only be imported and exported if specific statutory criteria are met. 
For instance, schedule II controlled substances may be imported to the 
extent that the Attorney General finds such importation is ``necessary 
to provide for the medical, scientific, or other legitimate needs of 
the United States * * * in any case in which the Attorney General finds 
that such controlled substance is in limited quantities exclusively for 
scientific, analytical, or research uses,'' 21 U.S.C. 952(a)(2)(C), or 
in other limited circumstances. Schedule II narcotic drugs may be 
exported if, inter alia, ``substantial evidence is furnished to the 
Attorney General by the exporter that (A) the narcotic drug is to be 
applied exclusively to medical or scientific uses within the country of 
import, and (B) there is an actual need for the narcotic drug for 
medical or scientific uses within such country.'' 21 U.S.C. 953(a)(4). 
Depending on the circumstances surrounding the proposed import or 
export, in most cases the CSA and implementing regulations require 
importers and exporters, in advance of the import or export, to obtain 
a permit from the DEA, or to report the activity to the DEA by filing a 
declaration. 21 U.S.C. 952-953, 971; 21 CFR 1312.11, 1312.21, 1313.12, 
1313.21.
1. Import and Export Permits for Controlled Substances
    Registrants (and those exempt from registration) \5\ who wish to 
import a

[[Page 63579]]

controlled substance listed in schedule I or II; any narcotic drug 
listed in schedule III, IV, or V; any non-narcotic drug in schedule III 
that has been specifically designated by regulation in 21 CFR 1312.30; 
or any non-narcotic substance listed in schedule IV or V that is also 
listed in schedule I or II of the Convention on Psychotropic 
Substances, 1971, must apply (on DEA Form 357) for and be granted a 
permit from the DEA prior to the import. 21 U.S.C. 952; 21 CFR 1312.11, 
1312.12, 1312.13. Similarly, registrants who wish to export any 
schedule I or II controlled substance; any narcotic drug in schedule 
III or IV; any non-narcotic drug in schedule III that has been 
specifically designated by regulation in 21 CFR 1312.30; or any non-
narcotic substance listed in schedule IV or V that is also listed in 
schedule I or II of the Convention on Psychotropic Substances, 1971, 
must apply (on DEA Form 161 or 161R) for and be granted a permit from 
the DEA prior to the export. 21 U.S.C. 953; 21 CFR 1312.21, 1312.22, 
1312.23. The DEA currently issues permits in sextuplet for imports and 
in septuplet for exports, serially numbered, on special paper. 21 CFR 
1312.13(e), 1312.23(e). The copies are distributed among the importer, 
the foreign exporter, the foreign government authority, CBP, and the 
DEA in accordance with Sec. Sec.  1312.14 and 1312.24. Permits expire 
on the date specified on the permit, but in no event shall the date be 
more than six months after the date the permit is issued. 21 CFR 
1312.16(b), 1312.25. Unused permits are required to be returned to the 
DEA for cancellation. Id.
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    \5\ As discussed in note 1, unless specifically noted otherwise, 
discussion of ``registrants'' also includes persons exempt from 
registration for purposes of the preamble portion of this notice.
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2. Import and Export Declarations for Controlled Substances
    Those non-narcotic controlled substances listed in schedule III, 
IV, or V, that are not subject to the requirement of a permit, may be 
imported or exported if the registrant files a controlled substances 
import/export declaration (on DEA Form 236) with the DEA. 21 U.S.C. 
952(b), 953(e); 21 CFR 1312.11(b), 1312.21(b). Likewise, narcotic 
controlled substances in schedule V may be exported if the registrant 
files a controlled substances export declaration. 21 U.S.C. 953(e); 21 
CFR 1312.21(b). Currently, the declaration must be executed in 
quintuplicate and Copy 4 shall be filed with the DEA not later than 15 
calendar days prior to the proposed date of importation or exportation. 
21 CFR 1312.18, 1312.19, 1312.27, 1312.28. The five copies of the 
import/export declaration (DEA Form 236) are distributed among the 
importer, the foreign shipper, the governmental authority of the 
foreign country, CBP, and the DEA in accordance with Sec.  1312.19 or 
Sec.  1312.28.
3. Import and Export Declarations and Notices for Listed Chemicals
    The CSA and DEA regulations have established a system of 
recordkeeping and reporting requirements that provide the DEA with a 
mechanism to track international movement of listed chemicals in order 
to prevent their being diverted for use in the clandestine manufacture 
of controlled substances. The CSA generally requires regulated persons 
who import or export a listed chemical to report the transaction to the 
DEA, as delegated by the Attorney General, at least 15 days in advance. 
21 U.S.C. 971(a). This requirement is modified for regulated persons 
engaging in a transaction with a ``regular customer'' and for regulated 
persons designated as ``regular importers.'' 21 U.S.C. 802 (36) and 
(37), 971(b); 21 CFR 1313.15, 1313.24. The DEA has the obligation to 
examine the report in order to determine if the shipment is legitimate 
and that the chemical will not be diverted into the illicit manufacture 
of controlled substances, pursuant to the authority granted in 21 
U.S.C. 971 (c) and (d).
    For listed chemicals at or above thresholds set forth in Sec.  
1310.04(f) and listed chemicals for which no threshold has been 
established as identified in Sec.  1310.04(g), regulated persons may 
import or export list I or II chemicals by filing a listed chemical 
import declaration (on DEA Form 486/486A) or an export declaration (on 
DEA Form 486) with the Administration not later than 15 calendar days 
prior to the date of the proposed importation or exportation (unless 
DEA has waived such advance reporting through regulation). 21 CFR 
1313.12, 1313.13, 1313.21, 1313.22. The United States importer or 
exporter must include on their declaration the name and address of each 
person to whom the listed chemical(s) will be transferred (i.e., the 
transferee, consignee, and intermediate consignees), including the 
quantity. 21 U.S.C. 971(d); 21 CFR 1313.13(c), 1313.22(c). For an 
importer, the transferee is the person to whom the importer transfers 
the listed chemical (i.e., the downstream customer). For an export from 
the United States, the transferee/consignee is the foreign importer. 
For a broker or trader, the transferee/consignee is the foreign 
customer purchasing the listed chemicals. Importers are also required 
to list their foreign supplier on their declaration. The DEA Form 486/
486A must be executed in triplicate. 21 CFR 1313.13, 1313.22. The three 
copies of the listed chemical import/export declaration are distributed 
among the importer/exporter, CBP, and the DEA in accordance with 
Sec. Sec.  1313.14 and 1313.23.
    If, after submission of the initial DEA Form 486/486A, the 
importer, exporter, broker or trader will not be transferring the 
listed chemical to the transferee named on the declaration, or if the 
quantity of listed chemical to be imported, exported, or transferred is 
greater than the quantity originally indicated on the declaration, the 
importer, exporter, broker or trader must file an amended DEA Form 486/
486A reporting the change. 21 CFR 1313.16(b), 1313.26(b), 1313.32(d). 
Even if an importer or exporter did not have to file an initial 
notification--either because he or she is a regular importer selling to 
a regular customer, or an exporter selling to a regular customer--if 
the newly arranged spot market sale is not to a regular customer, the 
importer or exporter must file an advance notice 15 days prior to 
transferring the chemical to a new customer. 21 CFR 1313.16, 1313.26.
    Within 30 days after an import or export of a listed chemical has 
occurred, the importer/exporter must file with the DEA a return 
declaration containing the particulars of the transaction, including 
the date, quantity, chemical, container, name of transferees, and any 
other information as the Administration may specify. 21 U.S.C. 971(g); 
21 CFR 1313.17(a), 1313.27(a). An importer may file a single return 
declaration including the particulars of both the importation and the 
distribution. 21 CFR 1313.17(a). If the importer has not distributed 
all chemicals imported by the end of the initial 30-day period, the 
importer must file supplemental return declarations every 30 days until 
the distribution or other disposition of all chemicals imported under 
the declaration or amended declaration have been accounted for. 21 CFR 
1313.17(a). If an import/export for which a declaration has been filed 
does not in fact take place, the importer/exporter must file an amended 
declaration notifying the DEA that the transaction did not in fact 
occur. 21 CFR 1313.17(b), 1313.27(b).
4. Import and Export Reports for Tableting and Encapsulating Machines; 
Reports for Domestic Transactions in Listed Chemicals, Gamma-
Hydroxybutyric Acid, and Tableting and Encapsulating Machines
    Regulated persons who engage in a regulated transaction involving a 
listed chemical, a tableting machine, or an

[[Page 63580]]

encapsulating machine must keep records of the transaction and file 
reports in accordance with Sec. Sec.  1310.03(a), 1310.04, and 1310.05. 
Regulated persons who import or export a tableting machine or 
encapsulating machine are not required to obtain prior approval from 
the DEA for the transaction, but they are required to file a report 
with the DEA of any importation or exportation of a tableting or an 
encapsulating machine on or before the date of importation or 
exportation. 21 U.S.C. 830(b)(1)(D); 21 CFR 1310.05(c), 1310.06 (e) and 
(f).
    Regulated persons who engage in an export transaction that involves 
ephedrine, pseudoephedrine, phenylpropanolamine, or gamma-
hydroxybutyric acid (including drug products containing these chemicals 
or controlled substance) and use or attempt to use the U.S. Postal 
Service or a private or commercial carrier are required to file monthly 
reports of these transactions in accordance with Sec. Sec.  1310.03(c), 
1310.05(e), 1310.06(i), and 1314.110; see also Sec.  1310.04. The 
report must be submitted to the Import/Export Unit of the DEA on 
company letterhead, signed by the person authorized to sign the 
registration application forms on behalf of the registrant. 21 CFR 
1310.05(e). Regulated persons who engage in any domestic regulated 
transaction with a tableting machine or an encapsulating machine, 
including those following an import of such machines, must orally 
report, when possible, and subsequently file written reports with the 
Special Agent in Charge of the DEA Divisional Office for the area in 
which the regulated person making the report is located. 21 CFR 1310.05 
(a)(4) and (b).
    Regulated persons are required to report regulated transactions 
involving extraordinary quantities of a listed chemical, uncommon 
method of payment or delivery, or other circumstances that the 
regulated person believes may indicate that the listed chemical will be 
used in violation of the CSA and its implementing regulations. 21 CFR 
1310.05 (a)(1) and (b). Regulated persons must also report the unusual 
or excessive loss or disappearance of a listed chemical under their 
control, 21 CFR 1310.05 (a)(3) and (b), and any proposed regulated 
transaction with a person whose description or identifying 
characteristic the Administration has previously provided. 21 CFR 
1310.05(a)(2).
5. Transshipments of Controlled Substances
    The transshipment of controlled substances through the United 
States is governed by 21 U.S.C. 954. Persons seeking to transship or 
transfer for immediate exportation schedule I controlled substances 
within the United States must apply for a permit at least 30 days in 
advance of the expected transshipment or, in the case of an emergency, 
as soon as practicable, and receive a transshipment permit from the DEA 
before the transshipment may occur. 21 CFR 1312.31. Controlled 
substances listed in schedule II, III, or IV may be so transshipped or 
transferred if 15 days advance written notice is provided to the DEA in 
accordance with 21 CFR 1312.32. 21 U.S.C. 954(2). A specific DEA Form 
is not required for transshipments, however the application for prior 
written approval (for schedule I substances) and the advance notice 
(for schedule II, III, or IV substances) must conform with very 
specific requirements outlined in Sec.  1312.31 (b) and (c). See 21 CFR 
1312.32(b).
6. Transshipments of Listed Chemicals
    As stated above, the CSA generally requires regulated persons who 
import or export a listed chemical to report the transaction to the 
DEA, as delegated by the Attorney General, at least 15 days in advance. 
21 U.S.C. 971(a). This requirement is modified for regulated persons 
engaging in a transaction with a ``regular customer'' and for regulated 
persons designated as ``regular importers.'' 21 U.S.C. 802 (36) and 
(37), 971(b); 21 CFR 1313.15, 1313.24. No waiver of the 15-day advance 
notice is permitted under 21 CFR 1313.31(d) for importations for 
transshipment purposes of threshold or greater quantities of listed 
chemicals. Regardless of whether the shipment is a direct export or a 
transshipment, the DEA has the obligation to examine the report in 
order to determine if the shipment is legitimate and that the chemical 
will not be diverted into the illicit manufacture of controlled 
substances.
    Persons seeking to transship or transfer listed chemicals in a 
quantity that meets or exceeds the threshold amounts found in Sec.  
1310.04(f) must provide advance notification to the DEA not later than 
15 days prior to the proposed date that the listed chemical will 
transship or transfer through the United States. 21 CFR 1313.31. The 
notification must contain the information that is required by the DEA 
Form 486, but it is not required to be submitted to DEA using the DEA 
Form 486.
7. Notifications of International Transactions by Brokers or Traders
    Brokers or traders engaging in international transactions involving 
listed chemicals which meet or exceed the threshold amounts found in 
Sec.  1310.04 must provide notification to the DEA not later than 15 
days in advance of the transaction by filing DEA Form 486. 21 CFR 
1313.32.
    Within 30 days after an international transaction has occurred, the 
broker or trader must send the DEA a return declaration containing the 
particulars of the transaction, including the date, quantity, chemical, 
container, name of transferees, and any other information as the 
Administration may specify. 21 CFR 1313.35(a). If an international 
transaction for which a DEA Form 486 has been filed does not in fact 
take place, the broker or trader must file an amended DEA Form 486 
notifying the DEA that the transaction did not in fact occur. 21 CFR 
1313.35(b).

C. Purpose of Regulatory Action

    The DEA is proposing to update its regulations regarding the import 
and export of tableting and encapsulating machines, controlled 
substances, and listed chemicals. In accordance with Executive Order 
13563, the DEA has reviewed its import and export regulations and 
reporting requirements for domestic transactions involving listed 
chemicals (and gamma-hydroxybutyric acid) and tableting and 
encapsulating machines, and evaluated them for clarity, consistency, 
continued accuracy, and effectiveness. The amendments would codify 
current practices and incorporate current procedures and technological 
advancements and allow for implementation of the President's Executive 
Order on streamlining the export/import process and requiring 
Government-wide utilization of the International Trade Data System 
(ITDS). Section 3 of the President's Executive Order 13659 of February 
19, 2014, ``Streamlining the Export/Import Process for America's 
Businesses,'' directs participating agencies to have capabilities, 
agreements, and other requirements in place to allow electronic filing 
through ITDS and supporting systems of data and other relevant 
documents (exclusive of applications for permits, licenses, or 
certifications) required for imported and exported goods. Businesses 
are able to transmit their import and export data according to the 
Electronic Data Interchange (EDI), an electronic communication 
framework providing standards for exchanging data via any

[[Page 63581]]

electronic means. Data transmitted through EDI links to the Automated 
Commercial Environment (ACE), which serves as the single window for CBP 
and participating agencies. For purposes of this notice, the DEA will 
describe EDI, ACE, and any successor system to ACE, by the statutory 
term for the single window goal, which is ITDS.
    As discussed above, current DEA regulations specifically require 
applications for permits, and declarations and other required notices 
and reports to be filed in paper form, or by electronic means in some 
circumstances. The DEA must amend its regulations in order to integrate 
DEA procedures related to the importation and exportation of tableting 
and encapsulating machines, controlled substances, and listed chemicals 
with the ITDS.
    Because the ITDS excludes applications for permits, licenses, or 
certifications, the ITDS single window will not be used by DEA 
registrants, regulated persons, or brokers or traders applying for 
permits or filing import/export declarations, notifications or reports 
with the DEA. The DEA import/export application and filing processes 
will continue to remain separate from (and in advance of) the ITDS 
single window. Entities will continue to use the DEA application and 
filing processes; however, the processes will be electronic rather than 
paper. After DEA's approval or notification of receipt as appropriate, 
the DEA will transmit the necessary information electronically to the 
ITDS and the registrant or regulated person so that customs officers 
can validate importations and exportations subject to DEA regulations.
    Because of the requirement that regulated persons submit reports of 
regulated transactions in tableting machines and encapsulating machines 
to the DEA, the DEA also proposes to require such domestic regulated 
transaction reports to be submitted through the DEA Office of Diversion 
Control secure network application, in addition to import and export 
regulated transactions. Mandatory reporting requirements for domestic 
regulated transactions are included as part of this proposal because it 
allows for the DEA to create, at one time, an efficient, streamlined 
reporting structure of regulated activities applicable to tableting and 
encapsulating machines. Additional information related to the proposed 
mandatory electronic reporting requirements for tableting and 
encapsulating machines is discussed in section II, B, 6, b of this 
document.
    This proposal additionally contains amendments that would implement 
section 4, Re-exportation Among Members of the European Economic Area, 
of the Improving Regulatory Transparency for New Medical Therapies Act, 
Public Law 114-89, which was signed into law on November 25, 2015. 
Section 4 amended section 1003 of the Controlled Substances Import and 
Export Act (21 U.S.C. 953) by making changes to paragraph (f) and 
adding paragraph (g) that allows for reexportation of controlled 
substances among members of the European Economic Area. Additional 
information related to the proposed revisions to implement section 4 of 
the Improving Regulatory Transparency for New Medical Therapies Act is 
discussed in section II, B, 8 of this document.
    This proposal also includes technical and stylistic changes to 
several regulations to clarify and simplify the language and to further 
the goals of the President's memorandum on Transparency and Open 
Government. 74 FR 4685, Jan. 26, 2009.

II. Discussion of Technical Amendments and Proposed Significant 
Regulatory Changes

A. Proposed Amendments Directly Associated With Implementation of the 
International Trade Data System

1. Applications, Notices, and Other Filings
    The principal changes necessary to implement the ITDS are also 
those that will allow the efficient and standardized electronic 
exchange of required information.
    To transmit data electronically to the ITDS, the first global 
change that the DEA is proposing is to mandate the electronic 
submission of all applications and other required filings and reports 
(e.g., declarations, notices, returns) associated with the importation 
or exportation of tableting and encapsulating machines, controlled 
substances, and listed chemicals. 21 U.S.C. 958(f). However, the DEA 
will not require electronic submission of transshipment data. (The 
electronic application and filing process is not feasible in such 
circumstances because foreign IP addresses are blocked by the 
Department of Justice's firewall and are prevented from accessing the 
DEA Office of Diversion Control secure network application.) 
Accordingly, the vast majority of persons subject to the CSA 
requirements and DEA regulations pertaining to imports and exports 
would be required to make all DEA-required submissions through the DEA 
Office of Diversion Control secure network application. The DEA will 
provide customs information to validate importations subject to DEA 
regulations, and this change will enable the DEA to analyze and 
electronically transmit necessary information to the ITDS quickly and 
accurately. The DEA Office of Diversion Control secure network 
application will be accessed by DEA registrants and regulated persons 
through the DEA Office of Diversion Control Web site. Security of the 
new electronic system is discussed in section II, A, 2 of this document 
under the heading ``Security.'' In addition, importers and exporters 
would obtain information regarding approved permits and DEA's receipt 
of completed declarations, notices, returns, and reports through the 
same DEA Office of Diversion Control secure network application. If 
importers and exporters were permitted to continue submitting paper 
documents, the DEA would have to manually transcribe the paper 
information into an electronic format for transmission to the ITDS. 
Such an intermediary step would cause unnecessary delay and is subject 
to error. In addition to providing for electronic filing of information 
to CBP through ITDS and reducing errors, electronic applications, 
approvals, declarations, notices, and reports strengthen the DEA's 
ability to monitor and prevent unauthorized imports and exports and 
will enhance information sharing between CBP/customs services of 
Insular Areas and the DEA.\6\ Electronic processing is expected to help 
the DEA identify unauthorized or suspicious shipments prior to import 
or export, and diversion of in-transit shipments being exported or 
imported, by improving the quality and timeliness of data review and 
transaction authorization.
---------------------------------------------------------------------------

    \6\ For purposes of this preamble, ``customs services of Insular 
Areas'' means the governmental authority/authorities (federal or 
insular), charged with enforcement of the customs laws of the United 
States/Insular Area.
---------------------------------------------------------------------------

    For the foregoing reasons, the DEA is proposing amendments to its 
regulations that would authorize electronic submission of data, and 
would make the procedure mandatory over paper in most circumstances. 21 
U.S.C. 958(f). The use of electronic applications and filings is 
consistent not only with the requirements of Executive Order 13659, but 
also with the general principles outlined in the Government's Open Data 
Policy which requires agencies to collect or create information in a 
way that supports downstream information processing and

[[Page 63582]]

dissemination.\7\ The Open Data Policy states that information should 
be collected electronically by default. As discussed in greater detail 
in the Regulatory Analyses section of this document, the DEA believes 
that the regulated community should be able to easily adapt to this new 
requirement with minimal effort or cost.
---------------------------------------------------------------------------

    \7\ OMB Memorandum M-13-13, Open Data Policy--Managing 
Information as an Asset, available at https://www.whitehouse.gov/sites/default/files/omb/memoranda/2013/m-13-13.pdf.
---------------------------------------------------------------------------

    If an importer/exporter tries to submit an application, 
declaration, notice, report, or other required submission through the 
DEA Office of Diversion Control secure network application but does not 
complete all of the required fields or enters key data that is not 
valid or is inaccurate (e.g., unknown port or erroneous drug code) with 
the submission, the DEA Office of Diversion Control secure network 
application will automatically alert the filer to the fact that 
information is missing or does not meet the validation requirements.
    Applications, declarations, notices, and reports filed through the 
DEA Office of Diversion Control secure network application would 
generally not be deemed filed until the DEA assigns a single-use, 
randomly-generated, unique identifier. This identifier would be 
referenced as the ``transaction identification number,'' except for 
permits, where the transaction identification number would continue to 
be called the ``permit number'' to correspond with current business 
practice. A permit number would be assigned once the DEA has approved 
an application for a permit. A transaction identification number would 
be assigned once the DEA reviews a declaration, notice, or other filing 
for completeness, and it is accepted for filing. Although issuance of a 
transaction identification number would signify that the declaration, 
notice, or other filing has been reviewed for completeness, the 
issuance of the transaction identification number does not mean that 
such filing has been ``approved'' by the DEA. The DEA reserves the 
right to cancel an import or export permit or declaration for cause and 
suspend shipments of listed chemicals in accordance with applicable 
regulations. Currently, the DEA assigns a Web Tracking Number to each 
filing submitted electronically to the DEA and would continue to do so 
under this proposal. However, unlike the proposed transaction 
identification number, the Web Tracking Number is assigned 
automatically upon submission to the DEA; the transaction 
identification number would be assigned only after the DEA has reviewed 
the filing for completeness.
    Instead of distributing ``copies,'' registrants and other 
importers/exporters, once logged into the DEA Office of Diversion 
Control secure network application through authenticated access, would 
be able to use the assigned permit or transaction identification number 
to access the ``official record'' of the filing from the DEA Office of 
Diversion Control secure network application. The registrant or other 
importer/exporter would then be responsible for forwarding official 
record information to their broker or any other of their agents needing 
the information contained therein to complete the release process 
through customs. Permit numbers and transaction identification numbers 
are discussed in more detail later in this document for each 
transaction category.
    Declarations, permits, and most other filings with DEA would not be 
deemed filed until a transaction identification number (or permit 
number) is issued by the DEA. The transaction identification number 
would be issued by the DEA after any necessary corrections are 
complete. The DEA considered, but ultimately did not choose to propose, 
a specific timeframe in which transaction identification numbers (and 
permit numbers) will be issued because of concern of instances that 
require longer-than-average review and processing times that can result 
from any number of circumstances, not all of which are foreseeable. 
However, the DEA does not have reason to believe that by not having a 
stated timeframe that there will be any significant impact on import 
and export activities.
    The DEA is proposing to have the option of deeming a submission 
filed on the date submitted, if a listed chemical import or export 
declaration, or other filing was complete at the time of filing and no 
additional follow-up action was required, instead of on the date the 
transaction identification number was issued. However, if a chemical 
importer or exporter made a submission on the last day that would 
comply with the reporting deadline, and DEA review subsequently found 
the submission not to be complete, then he or she would be in violation 
of the regulation. The requirement to submit applications, 
declarations, notices, reports, and other filings includes the duty 
that such filings be complete. If an importer or exporter has concerns 
that their information may not be complete they would be able to 
contact the DEA in advance of the submission to ask questions and/or 
submit the filing in advance of the deadline to ensure that if changes 
or additional information is required that those changes can be made 
before the established 15-day filing deadline.
    In association with this change, the DEA is proposing to globally 
amend its import and export regulations to provide that expiration 
periods, filing deadlines, and other timed action dates are to be 
generally calculated as ``calendar days'' (i.e., including weekends and 
holidays) unless otherwise noted in a regulation (e.g., in the case of 
amendments). This change corresponds with business rule policies that 
will be built into the DEA's electronic systems of records for the 
impacted applications, notices, and other filings that will be required 
to be electronically submitted to the DEA.
(a) Import and Export Permits for Controlled Substances
    The DEA proposes to incorporate the mandatory electronic 
application requirements for controlled substance imports and exports 
into Sec. Sec.  1312.12 and 1312.22. Applicants for a permit to import 
or export controlled substances would be required to access, complete, 
and submit the DEA application for import, application for export, or 
application for reexport, as appropriate, to the DEA through the DEA 
Office of Diversion Control secure network application. This 
requirement would also be incorporated into a new Sec.  1312.03, which 
references applicable forms for part 1312, and would state that such 
forms are electronic.
    Other than for transshipments, current DEA regulations requiring 
import and export permits to be issued in multiples via paper form 
would be eliminated in favor of regulations making such information 
available via digital means. The DEA would continue to issue original 
permits under existing practices, and would still transmit the original 
permit to the pertinent foreign competent national authorities (CNAs); 
however, the DEA would eliminate issuing the other copies. The DEA 
proposes that ``copies'' currently issued by the DEA to registrants 
would only be accessible through the DEA Office of Diversion Control 
secure network application. The DEA would assign each approved permit a 
permit number (a unique identifier). Once the permit has been issued, 
registrants would be able to use the assigned permit number to access 
the digital copy of the permit, or the ``official record of the 
permit.'' Corresponding changes would be made throughout DEA import/
export regulations. These changes will reference the data downloads 
from the

[[Page 63583]]

secure network application by the registrant as an ``official record of 
the permit'' instead of a ``copy.'' These changes are proposed in 
Sec. Sec.  1312.13, 1312.14, 1312.23, and 1312.24.
    The DEA proposes to amend its import/export regulations to describe 
the procedures relating to amendments following issuance of an import 
or export permit. The DEA is proposing to revise Sec. Sec.  1312.16 and 
1312.25 to clearly specify how and under what conditions controlled 
substance import and export permits may be amended or cancelled after 
issuance and when a new permit is required instead of an amendment. 
Registrants would submit a request to amend or cancel an application 
for an import or export permit, amend an issued import or export 
permit, or request for a cancelation of an issued import or export 
permit to the Administration through the DEA Office of Diversion 
Control secure network application. Return information on imports and 
exports may not be amended.
    Consistent with current practice, importers and exporters would 
continue to be able to request an amendment to a permit for the 
following data fields: The National Drug Control number, description of 
the packaging, or trade name of the product, so long as the description 
is for the same basic class of controlled substance(s) as in the 
original permit; the proposed port of entry or export; the proposed 
date of import or export; \8\ the method of transport; any registrant 
notes; and the justification entered by the importer or exporter for 
why an import or export is needed to meet the medical, scientific, or 
other legitimate needs of the United States or foreign jurisdiction. 
The DEA allows amendments to these fields as these are areas that may 
be easily mis-keyed or subject to change as part of the normal import 
and export business practice. While the data contained in these fields 
is important to determining the risk of diversion and the tracking of 
controlled substances through the closed system of distribution, the 
DEA believes that the Administration is able to enforce the CSA and 
uphold U.S. obligations under international drug control treaties while 
potentially limiting burden on industry by allowing these fields to be 
amendable.
---------------------------------------------------------------------------

    \8\ The DEA is proposing to make global changes to DEA 
regulations to change usage, where applicable, of ``import'' and 
``export'' to reference the date of release by customs officers for 
purposes of DEA recordkeeping and reporting requirements.
---------------------------------------------------------------------------

    Consistent with current practice, importers and exporters would 
continue to generally be allowed to amend the base weight of controlled 
substance(s) listed on their permit prior to the start of an import or 
export transaction (i.e., prior to shipment). However, also consistent 
with current practice, exporters would not be allowed to exceed the 
total base weight of controlled substance(s) listed on the 
corresponding foreign permit. Also consistent with current practice, 
neither would exporters be allowed to exceed the strength of a 
controlled substance product if product strength information has been 
included on the import permit issued by the foreign competent national 
authority. Consistent with current Sec.  1312.15(a), importers would 
continue to be allowed to request an amendment to the quantity of 
controlled substances specified on an import permit once a shipment has 
arrived at the U.S. customs port of entry if the increase in the amount 
of controlled substance to be imported is less than 1% of that listed 
on the issued import permit. Importers and exporters need not request 
an amendment for the sole purpose of decreasing the amount authorized.
    Consistent with current practice, importers and exporters would 
continue to be able to request that an import or export permit be 
amended to remove a controlled substance. However, importers and 
exporters would no longer be able to amend permits to add a new 
controlled substance, replace the name of a controlled substance with a 
different controlled substance, or amend the controlled substance 
content of a drug or preparation. Instead, importers and exporters who 
needed to make changes to any of these fields would need to cancel the 
existing permit and apply for a new permit. The DEA understands that 
sometimes the incorrect controlled substance is identified on the 
permit application due to clerical error, for example because a similar 
item was selected from the drop-down selection in the DEA Office of 
Diversion Control secure network application that was located near the 
correct item. However, the DEA has closely considered this issue and 
ultimately determined that because the listed controlled substance 
proposed to be imported or exported is such a critical element of 
determining whether or not a permit should be issued and, if issued, 
the amount allowed to be imported or exported, this element should not 
be amendable. As stated elsewhere in this preamble, the DEA reminds 
importers and exporters that the duty to file reports and other 
documents with the DEA includes the duty that these filings be complete 
and accurate.
    Similarly, in a change from current practice, the DEA is proposing 
to cease allowing exporters to amend foreign permit information on 
permit applications and issued permits. The DEA understands that 
sometimes, especially in the case of less experienced exporters, the 
incorrect foreign permit number is entered onto the permit application. 
This is often the result of numbers being transposed or a different 
number on the foreign permit being entered instead of the actual permit 
identification number. However, similar to the controlled substance 
identified on the permit, the DEA has closely considered this matter 
and ultimately determined that, because the authorization from the 
foreign competent national authority is such a critical element in 
determining whether a permit can be issued and the amount of the 
controlled substance to be exported, this element should not be 
amendable. As stated above and elsewhere in this document, the DEA 
reminds importers and exporters that the duty to file reports and other 
documents with the DEA includes the duty that these filings be complete 
and accurate.
    Consistent with current practice, importers and exporters would not 
be able to request an amendment to a permit for changes to the importer 
or exporter's name (as it appears on their DEA certificate of 
registration) or the name of the foreign importer or exporter. The DEA 
considers the name of the foreign importer or exporter to be a key 
factor in determining associated risks of the diversion of controlled 
substances and subsequently whether or not to issue an import or export 
permit. Therefore, these fields would not be amendable.
    However, also consistent with current practice, as stated above, 
the DEA would continue to allow importers and exporters to amend any 
additional associated company names they are DBA (doing business as) 
that they wish to have included in the notes section of the permit. The 
only change from current practice is that such amendments would be 
required to be made through the DEA Office of Diversion Control secure 
network application.
    Importers and exporters would be required to make an official 
request through the DEA Office of Diversion Control secure network 
application for an amendment. Supplementary information submitted by an 
importer or exporter through the DEA Office of Diversion Control secure 
network application would not automatically trigger the amendment 
process. An

[[Page 63584]]

amendment would have no effect on the date of expiration of the permit; 
an amended import or export permit would have the same expiration date 
as the originally issued permit. Return information would not be 
allowed to be amended. Importers and exporters would be able to request 
that an issued import or export permit be canceled provided that no 
shipment has yet been made.
    Under proposed Sec.  1312.16(a)(5), registrants would be required 
to submit all requests for an amendment that would affect the total 
base weight of each controlled substance, other than those submitted in 
accordance with Sec.  1312.15(a), at least three business days in 
advance of the date of release by a customs officer. Three business 
days are the minimum amount of time that the DEA needs to review this 
type of requested amendment, approve or deny the request, and transmit 
the applicable data to the ITDS. All other requests for amendment would 
be required to be submitted to the DEA at least one business day before 
the date of release by a customs officer at the port of entry. One 
business day is the minimum amount of time that the DEA needs to review 
the requested amendment, approve or deny the request, and transmit the 
applicable data to the ITDS.
    For the reasons discussed above, the DEA is also proposing 
mandatory electronic reporting of return information for controlled 
substances imported or exported under permit procedures. The 
requirement of return information for imports and exports under permit 
procedure is discussed in greater detail in section II, B, 1 of this 
proposal under the heading ``Terminology and Definitions.''
(b) Import and Export Declarations for Controlled Substances
    The DEA proposes to incorporate the mandatory electronic filing of 
DEA import declarations and DEA export declarations for controlled 
substances with the DEA into Sec. Sec.  1312.18 and 1312.27. This 
requirement would also be incorporated into a new Sec.  1312.03 which 
would reference a list of applicable forms for part 1312, and will 
state that the declaration forms are electronic. This information is 
currently listed multiple times in the applicable regulations. 
Consolidating this information into one section will make it easier for 
registrants to understand and comply.
    Consistent with current requirements, controlled substance 
declarations would be required to be filed at least 15 calendar days in 
advance of the antipcated date of release by a customs officer at the 
port of entry or port of export. 21 CFR 1312.18(b), 1312.27(a). Under 
proposed revised Sec. Sec.  1312.18(b) and 1312.27(a), controlled 
substance declarations would not be deemed filed until the 
Administration issues a transaction identification number. The DEA 
proposes to allow registrants to proceed with the import or export 
transaction as soon as the transaction identification number has been 
issued, regardless of whether 15 calendar days have elapsed since its 
issuance. The 15-day advance notification period currently required by 
DEA regulations is now used to review notifications. Under this 
proposal, that review period would occur prior to the issuance of the 
transaction identification number. Therefore, the DEA would no longer 
need additional processing time after the issuance of the transaction 
identification number. Therefore under this proposal, importers of 
controlled substances under declaration procedures would more closely 
align with import procedures under permit procedures in regard to 
timing as to when they may proceed with the transaction. The DEA 
proposes to retain the 15-day-advance time period to ensure enough time 
for the DEA to review the submission for completeness and conduct any 
necessary follow-up prior to the import/export transaction. As 
discussed above, transaction identification numbers would be single-use 
identifiers, unique to a specific communication or transaction (e.g., a 
notice, filing, report, application, etc.), signifying that a 
communication has been received, reviewed, and accepted. While current 
DEA regulations do not require confirmation of receipt from the DEA 
prior to importation or exportation pursuant to a declaration, the 
proposal to assign a transaction identification number is consistent 
with the DEA's current practice for declarations submitted online. 
Currently, the DEA assigns a Web Tracking Number to each declaration 
when it is submitted and accepted. However, unlike the proposed 
transaction identification number, the Web Tracking Number is assigned 
automatically upon submission to the DEA; the transaction 
identification number would be assigned only after the DEA has reviewed 
the filing for completeness. The proposed regulatory codification of 
the issuance of a transaction identification number is designed to 
ensure that electronically submitted declarations are indeed received 
by the DEA, are completed, and can be appropriately tracked and 
monitored; to streamline the declaration filing process; and to 
eliminate duplicate filings. Current DEA regulations requiring 
declarations to be completed in triplicate would be eliminated.
    The DEA proposes to amend its import/export regulations to describe 
the procedures relating to amendments following the filing of a 
controlled substance import or export declaration with implementation 
of the ITDS. The DEA proposes changes to Sec. Sec.  1312.18(f) and 
1312.27(e) to clearly specify how and under what conditions controlled 
substance import and export declarations may be amended or cancelled 
after having been filed and when a new declaration is required instead 
of an amendment. Registrants would submit a request to amend or cancel 
a filed declaration to the Administration through the DEA Office of 
Diversion Control secure network application. Return information may 
not be amended.
    Consistent with current practice, importers and exporters would 
continue to be able to amend a declaration for the following data 
fields: The National Drug Control number, description of the packaging, 
or trade name of the product, so long as the description is for the 
same basic class of controlled substance(s) as in the original 
declaration; the proposed port of entry or export; the anticipated date 
of release by a customs officer at the port of entry or port of export; 
the method of transport; any registrant notes; and the justification 
entered by the importer or exporter for why an import or export is 
needed to meet the legitimate scientific or medical needs of the United 
States or foreign jurisdiction. The DEA allows amendments to these 
fields as these are areas that may be easily mis-keyed or subject to 
change as part of the normal import and export business practice. While 
the data contained in these fields is important to the tracking of 
controlled substances through the closed system of distribution, the 
DEA believes that the Administration is able to enforce the CSA and 
U.S. obligations under international drug control treaties while 
potentially limiting burden on industry by allowing these fields to be 
amendable.
    Consistent with current practice, importers and exporters would 
continue to generally be allowed to amend the base weight of controlled 
substance(s) listed on their filed declaration prior to the start of an 
import or export transaction (i.e., prior to shipment). However, also 
consistent with current practice, exporters would not be allowed to 
exceed the total base weight of controlled substance(s) listed on the 
corresponding authorization for import

[[Page 63585]]

issued by the foreign competent national authority. Also consistent 
with current practice, neither would exporters be allowed to exceed the 
strength of a controlled substance product if product strength 
information has been included on the authorization for import issued by 
the foreign competent national authority. Consistent with Sec.  
1312.15(a) for imports of controlled substances under permit procedure, 
importers under declaration procedure would be allowed to request an 
amendment to an import declaration regarding the quantity of controlled 
substances once a shipment has arrived at the U.S. customs port of 
entry if the increase in the amount of controlled substance to be 
imported is less than 1% of that listed on the filed declaration. 
Importers and exporters need not request an amendment for the sole 
purpose of decreasing the amount authorized.
    Consistent with current practice, importers and exporters would 
continue to be able to amend a filed import or export declaration to 
remove a controlled substance. However, importers and exporters would 
no longer be able to amend declarations to add a new controlled 
substance or replace a controlled substance with another controlled 
substance. Instead, importers and exporters who needed to make changes 
to any of these fields would need to cancel the existing declaration 
and file a new declaration. The DEA understands that sometimes the 
incorrect controlled substance is identified on the declaration due to 
clerical error, for example because a similar item was selected from 
the drop-down selection in the DEA Office of Diversion Control secure 
network application that was located near the correct item. However, 
the DEA has closely considered this issue and ultimately determined 
that because the identification of the controlled substance proposed to 
be imported or exported is such a critical element of the closed system 
of distribution, that this element should not be amendable. As stated 
elsewhere in this preamble, the DEA reminds importers and exporters 
that the duty to file reports and other documents with the DEA includes 
the duty that these filings be complete and accurate.
    Similarly, in a change from current practice, the DEA is proposing 
to cease allowing importers and exporters to amend information related 
to the authorization to import or export from the foreign competent 
national authority. The DEA understands that sometimes, especially in 
the case of less experienced importers and exporters, the incorrect 
foreign authorization identifier is entered onto the declaration. This 
is often the result of numbers being transposed or a different number 
on the foreign permit being entered instead of the actual authorization 
identifier. However, similar to the identification of the controlled 
substance to be imported or exported, the DEA has closely considered 
this matter and ultimately determined that because the authorization 
from the foreign competent national authority to import or export a 
controlled substance is such a critical element to the Administration's 
ability to monitor and ensure the closed system of distribution, this 
element should not be amendable. As stated above and elsewhere in this 
document, the DEA reminds importers and exporters that the duty to file 
reports and other documents with the DEA includes the duty that these 
filings be complete and accurate.
    Consistent with current practice, importers and exporters would not 
be able to request an amendment to a filed import or export declaration 
for changes to the importer or exporter's name (as it appears on their 
DEA certificate of registration) or the name of the foreign importer or 
exporter. The DEA considers the name of the foreign importer or 
exporter to be a key factor in determining associated risks of the 
diversion of controlled substances. Therefore, these fields would not 
be amendable.
    However, also consistent with current practice, as stated above, 
the DEA would continue to allow importers and exporters to amend any 
additional associated company names they are DBA (doing business as) 
that they wish to have included in the notes section of the 
declaration. The only change from current practice is that such 
amendments would be required to be made through the DEA Office of 
Diversion Control secure network application.
    Importers and exporters would be required to make an official 
request through the DEA Office of Diversion Control secure network 
application for an amendment. Supplementary information submitted by an 
importer or exporter through the DEA Office of Diversion Control secure 
network application would not automatically trigger the amendment 
process. An amendment would have no effect on the date of expiration of 
the declaration; an amended import or export declaration would have the 
same expiration date as the originally filed declaration. Return 
information would not be allowed to be amended. Importers and exporters 
would be able to request that filed import or export declaration be 
canceled provided that no shipment has yet been made.
    Registrants would be required to submit all requests for an 
amendment that would affect the total base weight of each controlled 
substance, other than those allowed to be released into the United 
States pursuant to Sec. Sec.  1312.18(f) and 1312.16(a)(5), at least 
three business days in advance of the date of release by customs. Three 
business days are the minimum amount of time that the DEA needs to 
review this type of requested amendment and transmit the applicable 
data to the ITDS. All other requests for amendment would be required to 
be submitted to the DEA at least one business day before the 
anticipated date of release by a customs officer at the port of entry 
or port of export. One business day is the minimum amount of time that 
the DEA needs to review and accept the requested amendment and transmit 
the applicable data to the ITDS.
    For the reasons stated above, the DEA is also proposing mandatory 
electronic filing of return information for controlled substances 
imported or exported under declaration procedures; see section II, B, 1 
of this proposal under the heading ``Terminology and Definitions'' for 
additional discussion of ``return information.''
(c) Import and Export Declarations for Listed Chemicals
    The DEA proposes to incorporate the mandatory electronic filing of 
import and export declarations for listed chemicals into Sec. Sec.  
1313.12 and 1313.21. Similar to the proposed Sec.  1312.03, discussed 
above, the DEA is proposing a new Sec.  1313.03, which references a 
list of applicable forms for part 1313, and will state that the 
declaration is electronic.
    Under this proposal, the DEA would issue a transaction 
identification number once the DEA reviewed a listed chemical import or 
export declaration for completeness, and the 15-day reporting clock 
would begin on the date that the importer or exporter files a complete 
declaration. An import or export transaction of a listed chemical would 
not be allowed to take place until the transaction identification 
number has been issued and 15 calendar days have elapsed from the date 
a complete declaration was filed. Transaction identification numbers 
would be single-use numbers, unique to a specific transaction. While 
current DEA regulations do not require confirmation of receipt or 
acceptance from the DEA prior to importation or exportation pursuant to 
a declaration, the proposed

[[Page 63586]]

change aligns with current practices. In current practice, for 
notifications submitted through the DEA Office of Diversion Control 
secure network application and those that are not, industry waits until 
the transaction identification number has been issued to proceed with 
the transaction. The transaction identification number is assigned by 
the DEA only after the DEA has reviewed the filing for completeness. 
The proposed regulatory codification of current practices regarding the 
issuance of a transaction identification number is designed to ensure 
that electronically submitted declarations are indeed received by the 
DEA, are completed, and can be appropriately tracked and monitored; to 
streamline the declaration filing process; and to eliminate duplicate 
filings. Current DEA regulations requiring declarations to be completed 
in triplicate would be eliminated.
    The DEA is also proposing to amend the language relating to waivers 
of the 15-day advance reporting requirement for importations by 
``regular importers'' and export transactions between regulated persons 
and ``regular customers'' in Sec. Sec.  1313.12, 1313.15, and 1313.21. 
With the implementation of the ITDS, it would be difficult for customs 
officers to clear a shipment of relevant listed chemicals without first 
receiving appropriate information from the DEA. The DEA has determined 
that three business days is the minimum amount of time that the DEA 
needs to review the information regarding the shipment and to transmit 
the applicable data accurately to the ITDS. The CSA requires the DEA to 
provide by regulation the circumstances in which the 15-day advance 
notice requirement required by 21 U.S.C. 971(a) does not apply for 
imports of listed chemicals by ``regular importers'' and exports of 
listed chemicals between regulated persons and ``regular customers.'' 
21 U.S.C. 971(b). Pursuant to this authority, in the current 
regulations, the DEA has provided that specific circumstances allow for 
a waiver of the entire 15-day period of advance notification.\9\ 
Because a waiver of the entire 15-day period will no longer be feasible 
after implementation of the ITDS, the DEA proposes now to describe 
circumstances in which importers and exporters will not be subject to 
the 15-day advance notification requirement but must provide 3 
calendar-days advance notification. The DEA does, however, propose to 
allow registrants to proceed with the import or export transaction as 
soon as the transaction identification number has been issued, 
regardless of whether the 3-calendar-day period has concluded. While 
the CSA also requires regulated persons subject to waivers to notify 
the DEA of the transaction ``at the time of any importation or 
exportation,'' the DEA intends to consider the notification provided to 
the DEA by customs officers at the time of release to serve this 
statutory purpose.
---------------------------------------------------------------------------

    \9\ Importers should be aware that these waivers of advance 
notification requirements apply only to the information the trade 
files with the DEA; for example, importers remain required to follow 
CBP's Importer Security Filing and Additional Carrier Requirements 
(commonly known as ``10+2'') rule, which applies to import cargo 
arriving to the United States by vessel.
---------------------------------------------------------------------------

    The DEA is proposing to revise Sec. Sec.  1313.16, 1313.17, 
1313.26, and 1313.27 to clarify the procedure for amending listed 
chemical import and export declarations after filing. Importers and 
exporters of listed chemicals would submit a request to amend or cancel 
a filed declaration to the Administration through the DEA Office of 
Diversion Control secure network application. Return information may 
not be amended. Requirements regarding updated notices for change in 
circumstances in Sec. Sec.  1313.16 and 1313.26 would remain 
essentially the same. However, to accommodate implementation of the 
ITDS, the DEA would require that amendments be submitted through the 
DEA Office of Diversion Control secure network application. Importers 
and exporters for whom the 15-day advance reporting requirement has 
been partially waived pursuant to 21 U.S.C. 971(b) needing to make 
changes in advance of shipment, such as to increase the quantity of a 
listed chemical to be imported or exported, would be required to file 
their amendment at least three business days in advance of the date of 
release by a customs officer at the port of entry or port of export. As 
described above, three business days is the minimum amount of time that 
the DEA needs to review the amendment and transmit the applicable data 
to the ITDS.
    For the reasons stated above, the DEA is also proposing mandatory 
electronic filing of return information for listed chemicals imported 
or exported under declaration procedures; see section II, B, 1 of this 
proposal under the heading ``Terminology and Definitions'' for 
additional discussion of ``return information.''
(d) Import and Export Reports for Tableting and Encapsulating Machines
    The DEA proposes to incorporate mandatory electronic reporting 
requirements into Sec.  1310.05 for all regulated transactions 
involving tableting machines and encapsulating machines, including 
domestic, import, and export transactions. To standardize and 
streamline the electronic filing of these reports, the DEA proposes to 
implement usage of a new form, DEA Form 452, Reports for Regulated 
Machines, which would cover imports, exports, and domestic regulated 
transactions of tableting and encapsulating machines, and whose usage 
would be referenced in the revised regulations. The new form would be 
accessed, completed, and submitted by regulated persons entirely though 
the DEA Office of Diversion Control secure network application. Upon 
receipt and review, the Administration will assign each completed 
report a transaction identification number. The DEA Form 452 would not 
be deemed filed until the Administration issues a transaction 
identification number. As discussed above, transaction identification 
numbers would be single-use identifiers, unique to a specific 
communication or transaction (e.g., a notice, filing, report, 
application, etc.), signifying that a communication has been received, 
reviewed, and accepted. While current DEA regulations do not require 
confirmation of receipt from the DEA before the report is deemed filed, 
the proposed change is designed to ensure that electronically submitted 
reports are indeed received by the DEA, are completed, and can be 
appropriately tracked and monitored; to streamline the report filing 
process; and to eliminate duplicate filings. The current Sec. Sec.  
1310.05 and 1310.06 would be revised to reflect that these reports 
relating to tableting and encapsulating machines would now be submitted 
on the DEA Form 452.
    Currently, regulated persons must provide notification of the 
import or export of a tableting machine or encapsulating machine on or 
before the date of importation or exportation. 21 CFR 1310.05(c). The 
DEA is proposing to require that the DEA Form 452 be submitted to the 
DEA 15 calendar days before the anticipated date of arrival at the port 
of entry or port of export in order to allow time for the DEA to review 
the information and transmit it to the ITDS. In order for these reports 
to be effective, they must be communicated by the DEA to CBP prior to 
arrival of the shipment at the port. The DEA has received reports that 
under current regulatory procedures, which require reporting ``on or 
before'' the date of importation, CBP has encountered machines at a hub 
or port of entry for which the importer has not provided DEA with 
notification, and

[[Page 63587]]

that seizures have resulted.\10\ Under the revised regulations, an 
importer may not initiate an import or export transaction involving a 
tableting machine or encapsulating machine until the regulated person 
has been issued a transaction identification number from the 
Administration. The importer or exporter could proceed with the import 
or export of the machine(s) as soon as the transaction identification 
number has been issued. These changes are proposed in a revised Sec.  
1310.05(c). Correspondingly, the DEA is proposing to amend Sec.  
1310.05(c) to provide clear direction that regulated persons are to 
submit notification of import or export of tableting or encapsulating 
machines through the DEA Office of Diversion Control secure network 
application.
---------------------------------------------------------------------------

    \10\ As discussed in notes 5 and 9, and later in this document, 
the DEA is including in this proposal to make global changes to DEA 
regulations to change usage, where applicable, of ``import'' and 
``export'' to reference the date of release by customs officers for 
purposes of DEA recordkeeping and reporting requirements.
---------------------------------------------------------------------------

    The DEA is proposing in the revised Sec.  1310.06(e)(1)(v) that 
reports of importation of tableting or encapsulating machines include 
the reason for the importation. This information would assist the DEA 
in understanding the intended medical, commercial, scientific, or other 
legitimate use of the machine.
    Additionally, the DEA proposes to add a paragraph (c)(2) to Sec.  
1310.05 to address what regulated persons are to do in the event that 
an import shipment of tableting machines or encapsulating machines has 
been denied release by customs. Proposed requirements for denied 
shipments of imported tableting machines and encapsulating machines 
parallel the requirements for denied shipments of controlled substances 
and listed chemicals. Importers would be required to report to the 
Administration, through the DEA Office of Diversion Control secure 
network application, within 24 hours of denial, that the shipment was 
denied release by a customs officer into the United States and the 
reason for the denial. Under the proposal, denials of shipments must be 
reported whether or not the denial is based on a violation of the CSA 
or its implementing regulations. Reports of denied releases by customs 
officers at the port entry of tableting and encapsulating machines are 
needed to aid the DEA in identifying attempted unreported imports of 
tableting and encapsulating machines. The DEA does not believe that 
reports of shipments denied release from the United States at the port 
of export are required because the DEA should already have knowledge of 
those machines through reports of their previous import (if applicable) 
and domestic regulated transactions required by the current Sec.  
1310.05(a)(4) and (c). A new proposed Sec.  1310.06(g) would detail the 
information to be included in such report of denied release into the 
United States. If an importer subsequently receives notice from a 
customs officer that their shipment will be released into the United 
States, the importer would be required to file an amended DEA Form 452 
with the DEA before the shipment may be released. In such 
circumstances, the regulated person may seek to have the tableting 
machines or encapsulating machines released by customs upon receipt of 
a transaction identification number for the refiled and amended DEA 
Form 452 without regard to the 15-day advance filing requirement.
    For the reasons stated above, the DEA is also proposing mandatory 
electronic filing of return information for tableting and encapsulating 
machines imported or exported; see section II, B, 1 of this proposal 
under the heading ``Terminology and Definitions'' for additional 
discussion of ``return information.'' Return requirements would be 
incorporated into a new paragraph (h) in Sec.  1310.06 and the existing 
paragraphs in the section correspondingly relabeled. This proposed 
change and other proposed changes to part 1310 not directly associated 
with the implementation of ITDS are discussed in more detail in section 
II, B, 6, b of this document.
    The DEA also is proposing to revise the text that currently is 
located in Sec.  1310.06(g) to require reports relating to exports of 
machines that are refused, rejected, or otherwise deemed undeliverable 
to be made through the DEA Office of Diversion Control secure network 
application. This provision, which is proposed to be moved to Sec.  
1310.06(i), does not require the use of a DEA Form 452. The DEA also 
proposes to require these reports to be submitted ``at the earliest 
practicable opportunity'' rather than the current standard of ``within 
a reasonable time.'' This proposed change would conform reporting 
requirements for declared exports of machines which are refused, 
rejected, or otherwise returned to the statutory language of 21 U.S.C. 
830(b) which requires reports of regulated transactions in a tableting 
machine or encapsulating machine (including reports of importation or 
exportation of such machines) to be reported ``at the earliest 
practicable opportunity.''
(e) Transshipments of Controlled Substances
    Applications for transshipment permits would still be allowed to be 
submitted to the DEA via paper in accordance with the existing 
procedures under Sec.  1312.31 for schedule I controlled substances. 
Information will be posted to the DEA Office of Diversion Control Web 
site informing persons seeking to transship schedule I controlled 
substances how to submit an application for a transshipment permit. 
Advance notification of transshipments for schedule II, III, and IV 
controlled substances would also still be allowed to be submitted to 
the DEA via paper in accordance with the current Sec.  1312.32. The 
electronic application and filing process is not feasible in such 
circumstances because foreign IP addresses are blocked by the 
Department of Justice's firewall and are prevented from accessing the 
DEA Office of Diversion Control secure network application. Although 
the transshippers themselves would not have direct access to the 
instructions on the DEA Web site due to the firewall protection, it is 
the DEA's understanding that most transshippers have someone in the 
United States as a domestic presence facilitating the transaction who 
will be able to access the instructions. There is no change from the 
current operational system. The DEA also proposes to explicitly state 
in Sec. Sec.  1312.31 and 1312.32 that a separate filing is required 
for each shipment, conforming the requirements of this section with the 
requirements for imports and exports of controlled substances in part 
1312.
(f) Transshipments of Listed Chemicals
    Advance notification would still be allowed to be submitted to the 
DEA via paper in accordance with the existing procedures under Sec.  
1313.31 for persons seeking to import a listed chemical into the United 
States for transshipment. Advance notification would still also be 
allowed to be submitted to the DEA via paper in accordance with the 
existing procedures under Sec.  1313.31 for persons seeking to 
transfer, or transship listed chemicals within the United States for 
immediate exportation. The electronic application and filing process is 
not feasible in such circumstances because foreign IP addresses are 
blocked by the Department of Justice's firewall and are prevented from 
accessing the secure network application on the DEA Office of Diversion 
Control Web site. While a broker or trader for an international 
transaction might be able to electronically submit the required

[[Page 63588]]

information from a domestic IP address, for consistency and fairness 
across all transshipment activities, the DEA is proposing to allow 
paper applications and notices to continue for all transshipment 
transactions. Although the transshippers themselves would not have 
direct access to the instructions on the DEA Web site due to the 
firewall protection, it is the DEA's understanding that most 
transshippers have someone in the United States as a domestic presence 
facilitating the transaction who will be able to access the 
instructions. There is no change from the current operational system.
(g) Notifications of International Transactions by Brokers or Traders
    The DEA proposes to incorporate in Sec.  1313.32 the mandatory 
electronic filing of notifications of international transactions 
involving listed chemicals which meet or exceed the threshold amount 
identified in Sec.  1310.04. While current DEA regulations do not 
require confirmation of receipt from the DEA prior to conducting an 
international transaction, the DEA is proposing to amend Sec.  1313.32 
to require that notifications of international transactions would not 
be deemed filed until a transaction identification number has been 
issued by the DEA. This change is designed to ensure that 
electronically submitted notifications are received by the DEA, are 
completed, and can be appropriately tracked and monitored; to 
streamline the notification filing process; and eliminate duplicate 
filings.
2. Security
    The DEA's secure application authentication methods allow only 
authorized persons to gain access to the application and ensure that 
persons can only gain access in the roles in which they are authorized. 
Because the secure network application can only be accessed through 
authentication, verifying the legitimacy of the reporter/applicant is 
possible without a requirement for a signature. Additional security 
protections are based on the requirement that return information is 
tied to a specific transaction. The reporter must have knowledge of the 
applicable transaction identification number or permit number in order 
to file the required return information.
    Under this proposed rule, the application, completion, and filing 
processes would be electronic; however, the electronic equivalent of 
the current, fillable DEA paper applications and other forms for 
imports and exports would not be downloadable. Rather, persons would be 
able to securely download approved permits and filed declarations, 
notices, and reports in digital image format. The DEA would enable 
security measures on the downloaded documents to prevent fraud, 
forgery, or other misuse or manipulation.
    Applicants and registrants must provide effective controls and 
procedures to guard against theft and diversion of controlled 
substances. 21 CFR 1301.71(a). This includes responsibility for 
ensuring effective controls and procedures for which their agents and 
employees have access to and responsibility for completing and filing 
applications, notices, reports, and other filings required by DEA 
regulations, whether those filings be in paper format or electronic. 
Registrants must exercise caution in the consideration of employment of 
persons who have access to listed chemicals, who have been convicted of 
a felony offense relating to controlled substances or listed chemicals, 
or who have, at any time, had any application for registration with the 
DEA denied, had a DEA registration revoked, or surrendered a DEA 
registration for cause. 21 CFR 1309.72.
    The DEA also takes this opportunity to remind registrants, those 
exempt from registration, and regulated persons that they may not 
delegate their liability away to their agents or employees. 
Registrants, those exempt from registration, and regulated persons 
remain legally liable (jointly or severally) with their agents or 
employees for violations of the CSA. It is unlawful for any person to 
knowingly or intentionally import or export controlled substances; 
knowingly or intentionally bring or possess on board a vessel, 
aircraft, or vehicle a controlled substance; or manufacture, possess 
with intent to distribute, or distribute a controlled substance in any 
means other than those authorized by the CSA. 21 U.S.C. 960(a). Except 
as provided in the CSA, it is unlawful for any person to knowingly 
import or export a listed chemical with intent to manufacture a 
controlled substance; export a listed chemical in violation of the laws 
of the country to which the chemical is exported; serve as a broker or 
trader for an international transaction involving a listed chemical, if 
the transaction is in violation of the laws of the country to which the 
chemical is exported; import or export a listed chemical knowing or 
having reasonable cause to believe that the chemical will be used to 
manufacture a controlled substance; export a listed chemical, or serve 
as a broker or trader for an international transaction involving a 
listed chemical knowing or having reasonable cause to believe that the 
chemical will be used to manufacture a controlled substance in 
violation of the laws of the country to which the chemical is exported; 
import or export a listed chemical with the intent to evade the 
reporting or recordkeeping requirements of 21 U.S.C. 971; import a 
listed chemical in violation of 21 U.S.C. 952, import or export such a 
chemical in violation of 21 U.S.C. 957 or 971, or transfer such a 
chemical in violation of 21 U.S.C. 971(d); or manufacture, possess with 
intent to distribute, or distribute a listed chemical in violation of 
21 U.S.C. 959. 21 U.S.C. 960(d). It is unlawful for applicants, 
registrants, those exempt from registration, regulated persons, or 
agents or employees thereof, to knowingly and willfully falsify, 
conceal, or cover up by any trick, scheme, or device a material fact. 
18 U.S.C. 1001(a)(1). It is unlawful for applicants, registrants, those 
exempt from registration, regulated persons, or agents or employees 
thereof, to knowingly and willfully make false statements or 
representations. 18 U.S.C. 1001(a)(2). It is unlawful for applicants, 
registrants, those exempt from registration, regulated persons, or 
agents or employees thereof, to knowingly and willfully make or use any 
false writing or document knowing it to contain materially false, 
fictitious, or fraudulent statement or entry. 18 U.S.C. 1001(a)(3).
    It is the position of the DEA that an employee who has knowledge of 
diversion of controlled substances or listed chemicals from his 
employer by a fellow employee has an obligation to report such 
information to his employer. 21 CFR 1301.91, 1309.73.
3. Miscellaneous
    To account for approvals by the Administration through the DEA 
Office of Diversion Control secure network application, DEA regulations 
would be amended to remove the reference to facsimile signatures found 
in Sec.  1312.13 for import permits. To account for greater security 
and decrease opportunities for diversion, the DEA also proposes to 
eliminate the current requirements in Sec. Sec.  1312.13 and 1312.23 
that import and export permits be issued sequentially and instead 
assign each permit a unique, randomly-generated identifier.
    Pursuant to E.O. 13659 (ITDS), the DEA would cease distributing 
paper copies of permits and declarations to CBP/customs services of 
Insular Areas. Instead, the DEA would electronically transmit pertinent 
data fields from the permit, declaration, or other notice to the ITDS.

[[Page 63589]]

    To accommodate the change in practices concerning the exchange of 
information between the DEA and CBP/customs services of Insular Areas 
as part of the implementation of the ITDS, the DEA proposes to 
generally, globally remove current DEA regulations that address the 
transmission and review of import and export information between the 
DEA and CBP. The regulations that would be affected are Sec. Sec.  
1312.14, 1312.19, 1312.24, 1312.28, 1313.14, and 1313.23. The removal 
of these regulations will allow for increased flexibility to make 
adjustments regarding the transmission of information between the DEA 
and CBP/customs services of Insular Areas as the process is 
implemented. No changes or modifications in the exchange of information 
between the DEA and CBP/customs services of Insular Areas should have 
any impact on those entities that must utilize the DEA Office of 
Diversion Control secure network application to submit applications or 
filings. The DEA is not proposing to remove current operational 
requirements found in Sec.  1312.15, ``Shipments in greater or less 
amount than authorized.''

B. Proposed Amendments Indirectly Associated With Implementation of the 
International Trade Data System

1. Terminology and Definitions
    For purposes of clarity and transparency, the DEA proposes to 
update its regulations for consistency of terminology (within DEA 
regulations, between DEA regulations and the CSA, and between DEA 
regulations and the regulations of other agencies that regulate imports 
and exports), to reflect name changes to referenced entities, and to 
add new definitions. These changes involve both technical and 
substantive amendments.
    The DEA proposes to make technical changes to update references to 
certain named entities. One, all references to the ``U.S. Customs 
Service'' will be changed to ``U.S. Customs and Border Protection'' 
(CBP). In 2003, the functions of the Customs Service were transferred 
to the Department of Homeland Security (DHS). Its successor agency is 
known as U.S. Customs and Border protection (CBP). Two, the DEA is 
making a change in Sec.  1310.06 to change ``Federal Food and Drug 
Administration'' to the agency's formal name, the ``U.S. Food and Drug 
Administration.'' Three, the DEA will amend current Sec.  1312.12(b) 
(proposed Sec.  1312.12(c)) to reflect that the cities located in the 
Republic of India currently referenced as Calcutta and Bombay are now 
recognized by the U.S. State Department as Kolkata and Mumbai. The DEA 
will also take this opportunity to remove any remaining incongruous 
references to the ``Director'' when referencing the head official of 
the DEA and alternatively insert the term ``Administrator'' or 
``Administration'' as appropriate.
    Additionally, the DEA proposes to make a technical change to more 
concisely incorporate U.S. obligations under international treaties of 
drug control, as statutorily codified in the CSA. The DEA will amend 
its regulations to consistently reference the ``competent national 
authority'' when referencing a foreign jurisdiction having authority to 
authorize the importation or exportation of controlled substances and 
listed chemicals into or out of their jurisdiction. This change is 
being accompanied by the addition of a definition in the regulations 
for ``competent national authority.'' A competent national authority 
(CNA) is an entity that has authority to authorize imports and exports 
of narcotic drugs and psychotropic substances and regulate or enforce 
national controls over precursor and essential chemicals. Generally, 
the only entities recognized as such by the DEA are those entities 
identified in the directory of ``Competent National Authorities Under 
the International Drug Control Treaties'' published by the United 
Nations Office on Drugs and Crime. However, for purposes of exports of 
narcotic drugs, such term also includes freely associated states 
eligible to receive exports of narcotic drugs from the United States 
pursuant to 48 U.S.C. 1972.
    The DEA will remove ``jurisdiction of the United States'' as a 
defined term in Sec. Sec.  1300.01(b) and 1300.02(b) but will add a 
clarification of the definition of the term ``United States'' in those 
provisions. Although the term ``United States'' is defined at 21 U.S.C. 
802(28), the proposed definitions in the regulations will clarify the 
Administration's interpretation and make the reader aware that places 
and waters subject to the jurisdiction of the United States, in 
addition to the customs territory of the United States, include (but 
are not limited to) the U.S. territories or possessions listed in the 
new term. The list of territories and possessions is not a catalogue of 
Insular Areas where the CSA is in effect. Rather, these listed 
territories or possessions (U.S. Virgin Islands, Guam, American Samoa, 
and the Northern Mariana Islands) are ones that are permanently 
inhabited. Thus, they are ones from which controlled substances, listed 
chemicals, and tableting or encapsulating machines might be expected to 
be regularly imported into the customs territory of the United States 
(or exported to foreign jurisdictions), as well as ones into which such 
materials may be imported from foreign jurisdictions, all of which 
would require compliance with the Administration's import and export 
regulations. No substantive change is intended by this revision. 
Removal of the definition of ``jurisdiction of the United States'' and 
corresponding changes to remove the term in Sec. Sec.  1301.12, 
1301.34, and 1302.07, as well as in the definitions of ``export'' and 
``import'' in 21 CFR part 1300, will make DEA regulations consistent 
with the CSA. The DEA proposes to remove the phrase ``jurisdiction of 
the United States'' from Sec.  1301.12(b)(3) because it is redundant 
with the preceding clause referencing registration at another location 
in the same State, as ``State'' is broadly defined in 21 U.S.C. 
802(26). The addition of the phrase ``in which he practices'' to Sec.  
1301.12(b)(3) would conform the regulation to registration requirements 
for practitioners as stated in 21 U.S.C. 823(f). No substantive change 
is intended by this amendment. Similarly, the clause ``within and 
without the jurisdiction of the United States'' would be removed from 
Sec.  1301.34(c)(2) as it is superfluous with the first portion of that 
regulation. No substantive change is intended by this amendment. In 
determining whether it is in the public interest to issue a 
registration to import schedule I or II controlled substances, the DEA 
considers employment of security procedures to guard against in-transit 
losses both domestically and abroad and will continue to do so. The 
term ``jurisdiction of the United States'' is also found in the 
definition of ``chemical import.'' The DEA proposes to remove that 
definition as unnecessary and superfluous, as it is only used once in 
subsequent DEA regulations, in Sec.  1313.14 in reference to ``listed 
chemical import declarations.''
    In association with the above, the DEA also proposes to amend 
Sec. Sec.  1301.24, 1301.26, 1309.26, 1312.13, and 1312.15 to denote 
the responsibility of customs services of Insular Areas, and not just 
CBP, to enforce the import and export requirements of the CSA. When 
controlled substances, listed chemicals, and tableting or encapsulating 
machines are imported into, or exported from, a U.S. territory (or 
possession) or an Insular Area of the United States that is not part of 
the customs territory of the United States, these items are cleared by

[[Page 63590]]

the customs service of an Insular Area and not CBP.\11\
---------------------------------------------------------------------------

    \11\ Although the U.S. Virgin Islands are outside the customs 
territory of the United States, the customs laws of the U.S. Virgin 
Islands are enforced by U.S. Customs and Border Protection. 19 CFR 
7.2(c).
---------------------------------------------------------------------------

    The DEA proposes to make global amendments to its import and export 
regulations where appropriate to reference the date of ``release'' by 
customs officers of items entering or departing the United States 
rather than the date of ``import'' or ``export'' where such terms are 
currently used in DEA regulations establishing DEA recordkeeping and 
reporting requirements (as compared to determining liability under the 
CSA as a result of items entering or leaving places and waters subject 
to the jurisdiction of the United States). This change will make clear 
that the DEA does not equate the ``date of import'' and ``date of 
export'' with the date that a customs officer ``releases'' an item that 
has been imported or an item intended or destined for export. As noted 
earlier in the document, the meaning of import and export under the CSA 
is much broader than how those terms may be used by other agencies 
exercising import or export control pursuant to organic statutes other 
than the CSA (i.e., the actual date of import or export under the CSA 
may, and frequently will, occur at a date different than the date of 
release by a customs officer).
    The DEA proposes to make a technical amendment to remove references 
to telex and facsimile number contact information found in various 
sections of 21 CFR part 1313, as telex systems and facsimile machines 
are now rarely utilized by registrants, regulated persons, or their 
agents. The DEA would add a general reference to ``contact 
information.'' This change is intended to account for contact 
information systems such as email now in common usage as well as other 
forms of communication which may be developed in the future.
    The DEA proposes to make a technical amendment to replace all 
current references in DEA regulations to ``special controlled 
substances invoice(s)'' with ``export declaration(s).'' This change 
will conform terminology among the DEA Form 236, DEA regulations, and 
current practice.
    The DEA is proposing global technical amendments related to plain 
language principles. The DEA has tried to balance the redrafting of 
regulatory language to better correspond with Federal Plain Language 
Guidelines against the knowledge that regulated persons have historical 
familiarity with long-standing regulatory text which may have been the 
subject of previous interpretation by the Administration and court 
decisions. Many of the DEA's current import and export regulations have 
not ever been significantly modified since the original requirements 
were implemented under predecessor drug control statutes (with 
reimplementation under authority of the CSA). The DEA has tried to 
balance the historical knowledge of the Administration and presently 
regulated individuals against the need for newly regulated persons and 
a broader segment of the population to be able to more easily read and 
comprehend applicable requirements. These proposed changes include 
changing the word ``shall'' to ``must,'' ``desiring'' to ``seeking,'' 
and ``furnish'' to ``file,'' without intending any change to the 
meaning of existing regulations. The DEA is proposing technical 
amendments throughout the revised regulations to eliminate use of 
passive voice in favor of the active voice. This change will make it 
easier for readers to identify what actions must be taken and by whom. 
The DEA's proposal would also eliminate unnecessary content and 
unnecessary words and phrases from regulations. The proposal also 
includes reorganization of several regulations to group reporting 
requirements for specific individuals or types of reports. This change 
will help to reduce the need to cross-reference between multiple 
regulations in order to more easily understand at a glance if you must 
report, when you must report, what you must report, and how you must 
report.
    The DEA also proposes to amend various import and export 
regulations related to the maintenance of records to add a cross 
reference to 21 CFR part 1304 or 1310, as applicable, which are the 
general parts governing recordkeeping and reporting responsibilities 
related to controlled substances and listed chemicals, respectively.
    In addition to the above noted technical changes, the DEA proposes 
to define the terms ``customs officer,'' ``port of entry,'' ``port of 
export,'' ``return information,'' and ``shipment'' currently utilized 
in DEA regulations. Defining these terms will add clarity and 
transparency as to how these terms are utilized for the specific 
purposes of DEA regulations related to the import and export of 
tableting and encapsulating machines, controlled substances, and listed 
chemicals as compared to how these terms may be used by other federal 
agencies having additional authorities over import or export. The 
proposed DEA definitions are substantially similar to how these terms 
are used by other agencies with overlapping authority over import and 
export. However, the definitions are not exact duplications because of 
the unique obligations and requirements imposed on imports and exports 
of controlled substances, listed chemicals, and tableting and 
encapsulating machines by the CSA. Most specifically, DEA regulations 
must take into account that the CSIEA defines ``import'' in broader 
terms than just in relation to the customs territory which is used as 
the basis for CBP's definition of ``date of importation'' and related 
terms. Similarly, CBP's definition of ``port of entry'' is defined 
narrowly to reference only the authority of CBP officials, whereas DEA 
regulations also need to take into account the authority of customs 
officials of Insular Areas of the United States to enforce the CSA.
    The proposed definition of ``customs officer'' makes clear that for 
purposes of DEA regulations, the term means any person authorized to 
enforce the customs laws of the United States. Consistent with 21 
U.S.C. 951-953 and other provisions of the CSA, the term ``customs 
officer'' includes customs officers of any commonwealth, territory, or 
possession of the United States. Correspondingly, in defining ``port of 
entry,'' the DEA's goal is to improve readability and transparency, and 
to clarify that applicable regulations regarding the importation of 
tableting and encapsulating machines, controlled substances, and listed 
chemicals apply to all locations at which these machines and substances 
may potentially be imported. See 21 U.S.C. 951(a)(1). The proposed 
definition of such locations include, but are not limited to, ports of 
entry as defined in title 19 of the United States Code, customs 
stations, landing rights airports, and user fee airports. Relatedly, 
the DEA is proposing to add a definition for ``port of export'' and 
make technical amendments throughout the export regulations to 
consistently refer to the ``port of export.'' Current DEA regulations 
variously refer to the point at which goods are released by customs 
officers for export from the United States as both the ``port of exit'' 
and the ``port of exportation.'' The proposed definition of ``port of 
export'' is based on the definition of the term in the Foreign Trade 
Regulations. 15 CFR 30.1. The Foreign Trade Regulations are promulgated 
by the U.S. Census Bureau, the Federal agency responsible for 
collecting, compiling, and publishing trade statistics for the United 
States pursuant to title 13, U.S.C., chapter 9. While the proposed 
definition is not an

[[Page 63591]]

exact duplication, due to the different authorities and 
responsibilities of the respective agencies, no significant substantive 
differences are intended. By basing the DEA's definition of ``port of 
export'' on 15 CFR 30.1, consistency of meaning, despite the unique 
requirements of the CSA, for the term will be achieved throughout the 
import and export process for persons who are subject to regulation by 
various Federal agencies.
    ``Shipment'' is variously defined by the federal entities having 
authority over importation and exportation of goods. The addition of a 
definition of this term in DEA regulations will aid in readability and 
transparency on how this term is understood and utilized by the DEA in 
regard to the importation and exportation of tableting and 
encapsulating machines, controlled substances, and listed chemicals. 
Introduction of the proposed definition emphasizes requirements found 
in 21 CFR parts 1310, 1312, and 1313 that a shipment of tableting or 
encapsulating machines, controlled substances, or listed chemicals is 
not only limited to a single transaction between a single importer or 
exporter and a single consignee on a single loading document, but also 
that the shipment must occur on a single conveyance (e.g., one plane, 
one ship, or one freight train--but not each rail car), as opposed to 
multiple conveyances (e.g., two planes, two ships, two freight trains, 
or any combination thereof). This definition is not meant to preclude 
release of merchandise into the United States that has been 
transshipped at a location outside of the United States. This is meant 
to clarify that each individual shipment of tableting or encapsulating 
machines, controlled substances, or listed chemicals must be associated 
with a single filing with the DEA for such activity. Consistent with 
long-standing DEA policy and the proposed definition, a load of goods 
would be considered a ``split shipment'' if it is divided into multiple 
parts to be placed onto more than one conveyance, even if on the same 
commercial loading document. Under existing DEA policy and under these 
proposed regulations, such ``split shipments'' cannot be included on a 
single declaration or permit. Each part of such shipment constitutes a 
shipment in its own right and requires a separate permit or declaration 
pursuant to these proposed changes. This addition of the definition, as 
proposed, would not change the ability of registrants to include 
multiple line items on one permit application, declaration, or notice. 
Neither is the definition meant to preclude the ability of importers 
and exporters to utilize multiple common carriers as intermediaries for 
the transportation of an entire shipment. Thus, for example, a shipment 
consisting of lots A and B, subject to a single valid export permit or 
declaration, can be reloaded together from one conveyance to another 
(such as from a freight train to a plane on its way to the port), but 
lots A and B cannot be separated from each other onto separate 
conveyances (such as onto separate planes or separate ships) at any 
time until the shipment has reached its final destination and the 
export transaction concluded. (The same being true in reverse for 
imports until delivered to the registered location.) Likewise, lot A 
cannot be subdivided into lots A1 and A2 unless lots A1 and A2 are 
subject to separate valid permits or declarations. In relation to this 
change, and for consistency with the existing single-shipment 
requirements found in 21 CFR parts 1312 and 1313, the DEA proposes to 
amend Sec.  1310.05(c)(1) to specify that each shipment of tableting or 
encapsulating machines must be reported separately to the DEA. To 
further make clear this prohibition, the DEA proposes to add a 
definition of ``split shipment'' to mean an import or export shipment 
that is divided between two or more conveyances.
    Additionally, the DEA is proposing to amend Sec. Sec.  1304.21(d) 
and 1310.06 to clarify record keeping requirements concerning imports 
and exports. The current text of Sec.  1304.21(d) states that the date 
of importation or exportation is the date on which the controlled 
substances are ``actually'' imported or exported. The DEA is proposing 
to amend these regulations to instead require that in maintaining 
records concerning imports and exports, the registrant needs to record 
the date on which the items are released by a customs officer at the 
port of entry or port of export. However, it should be understood that 
this clarification only applies for purposes of recordkeeping. For all 
other purposes under the CSIEA, the date of import or export is the 
date such activity actually occurs within the meaning of those terms 
under the Act. See 21 U.S.C. 951 through 953. The regulation remains 
unchanged with respect to recording dates of receipt and distribution, 
i.e., the dates will remain the actual date received at the registered 
location and distributed from the registered location.
    The DEA is additionally proposing to add a definition of ``return 
information'' to Sec. Sec.  1300.01(b) and 1300.02(b) stating that such 
information references information that persons are required to report 
to the Administration following an import or export transaction. While 
this term is already generally understood by the regulated community, 
the term is not defined, and may cause initial confusion to the general 
public or parties that are newly subject to DEA reporting requirements.
    The DEA proposes to harmonize the return information requirements 
across parts 1310, 1312, and 1313, to the extent possible. This 
document discusses the details of each proposal in the relevant section 
below. In general, the DEA is proposing that return information must be 
reported within 30 calendar days after release by customs at the port 
of entry or exit, or within 10 calendar days of a written request by 
the Administration, whichever is sooner. All return information for 
applications or other initial filings that are required to be made 
electronically through the DEA Office of Diversion Control secure 
network application would likewise be required to be filed 
electronically through the same system. Because the secure network 
application can only be accessed through authenticated access that 
ensures the legitimacy of the reporter/filer, and because the user must 
know the applicable transaction identification number or permit number 
in order to input return information for a specific transaction, the 
DEA does not see a need for return information to be signed by a 
responsible company official. Therefore, the DEA is proposing to remove 
the requirement for signature by a responsible company official that 
currently appears in Sec.  1312.22(c)(7).
2. Part 1302: Labeling and Packaging Requirements for Controlled 
Substances
    Corresponding to the removal of ``jurisdiction of the United 
States'' and the revised definitions of ``export'' and ``import,'' the 
DEA proposes to make a corresponding technical change to Sec.  1302.07 
to reflect those definitional changes. The sealing requirement would be 
separately stated for imports and exports. This change allows the 
import statement to clearly reflect that the sealing requirement for 
imported controlled substances applies regardless of whether the import 
occurred inside or outside of the customs territory of the United 
States. Separating the import and export requirements also makes clear 
that the distinction between the customs territory and the non-customs 
territory is only applicable to imports and not exports.

[[Page 63592]]

3. Part 1304: Records and Reports for Registrants
    The DEA proposes to make a technical amendment to Sec.  1304.02 to 
reflect that definitions found in Sec.  1300.02, ``Definitions relating 
to listed chemicals,'' are not applicable to part 1304, that addresses 
the records and reports that are required of controlled substance 
handlers. (21 CFR part 1310 addresses records and reports of listed 
chemicals and certain machines.)
    As discussed in section II, B, 1 of this document above, the DEA 
will make a technical amendment to amend Sec.  1304.21(d) to separately 
state reporting requirements concerning imports and exports of 
controlled substances. The recording date for receipt, distribution, 
other transfer, or destruction would not change. The regulation would 
be amended to state that the recording date for imports or exports of 
controlled substances is the date on which the controlled substance was 
released by a customs officer at the port of entry or port of export.
4. Part 1308: Schedules of Controlled Substances
    The DEA proposes to make two technical updates to part 1308. First, 
the DEA would amend Sec.  1308.01 to denote that part 1308 also 
includes nonnarcotic substances, chemical preparations, veterinary 
anabolic steroid implant products, prescription products, and anabolic 
steroid products excluded pursuant to 21 U.S.C. 811. Second, the DEA 
would amend Sec.  1308.49 to reflect the current requirements of the 
CSA regarding issuance of temporary scheduling orders. 21 U.S.C. 811(h) 
was amended by section 1153 of the Food and Drug Administration Safety 
and Innovation Act of 2012, Public Law 112-144, July 9, 2012, to make 
temporary scheduling orders effective for two years, with an option to 
extend for up to one year during the pendency of proceeding under 21 
U.S.C. 811(a). The CFR was not updated when the law changed. The DEA 
also proposes to realign the subsections of Sec.  1308.49 to properly 
separate the discussion of the circumstances in which a temporary 
scheduling order will be vacated.
5. Part 1309: Registration of Manufacturers, Distributors, Importers 
and Exporters of List I Chemicals
    The DEA proposes to amend Sec.  1309.32(d) to add ``manufactured'' 
to the list of business activities each application can include for 
each list I chemical. Adding ``manufactured'' would accurately reflect 
an ``activity'' that an applicant could conduct with list I chemicals 
if appropriately registered. No change is required to DEA Form 510 
because ``manufacturer'' is already listed as an option.
    The DEA is proposing to correct and update the cross-reference in 
Sec.  1309.46(d) by removing the reference ``Sec.  1309.54'' and 
replacing it with the reference ``Sec.  1309.53.'' Section 1309.46(d) 
currently instructs an applicant to file a request for a hearing 
pursuant to Sec.  1309.54. However, Sec.  1309.54 is entitled ``Burden 
of Proof,'' and therefore is an inaccurate cross-reference.
    The DEA is proposing to correct and update the cross-reference in 
Sec.  1309.51(a) by removing the cross-reference to Sec.  1309.57 and 
replacing it with the cross-reference ``1309.55.'' Currently, Sec.  
1309.57 is a misleading cross-reference since it does not exist in 
Title 21, chapter II of the CFR. The ``Hearings'' section in part 1309 
concludes at Sec.  1309.55. The DEA is therefore changing the cross-
reference in Sec.  1309.51(a) from ``1309.57'' to ``1309.55.'' Finally, 
the DEA is proposing to correct two minor typographic issues in Sec.  
1309.71.
6. Part 1310: Records and Reports of Listed Chemicals and Certain 
Machines
a. Mail Order Reporting for Ephedrine, Pseudoephedrine, 
Phenylpropanolamine, and Gamma-Hydroxybutyric Acid
    The DEA proposes to incorporate mandatory electronic reporting 
requirements into part 1310 for monthly reports of mail-order 
transactions involving ephedrine, pseudoephedrine, phenylpropanolamine, 
and gamma-hydroxybutyric acid (including drug products containing these 
chemicals or controlled substance) required to be filed in accordance 
with Sec.  1310.03(c) pursuant to 21 U.S.C. 830(b)(3). To standardize 
and streamline the electronic filing requirement of these monthly mail-
order reports, the DEA proposes to implement usage of a new form, DEA 
Form 453, which would be referenced in the revised regulations. The new 
form would be accessed, completed, and submitted by regulated persons 
entirely through the DEA Office of Diversion Control secure network 
application. 21 CFR 1310.03(c) would be further revised to reflect that 
reports would not be deemed filed until the Administration issues a 
transaction identification number unless they are complete upon 
submission. As discussed earlier in this document, transaction 
identification numbers would be single-use identifiers, unique to a 
specific communication, signifying that a communication has been 
received, reviewed, and accepted by the DEA. While current DEA 
regulations do not require confirmation of receipt from the DEA before 
the report is deemed filed, the proposed change is designed to ensure 
that electronically submitted reports are indeed received by the DEA, 
are complete, and can be appropriately tracked and monitored; to 
streamline the report filing process; and to eliminate potential 
duplicate filings. The current Sec.  1310.06(i) would be revised to 
reflect that the monthly mail-order information required to be 
submitted would now be submitted on the DEA Form 453 and would be 
designated as Sec.  1310.06(k). 21 CFR 1310.03(c) would be further 
revised by separately listing the requirement for monthly reports to be 
submitted by regulated persons who engage in the specified domestic 
mail-order transactions and export transactions. The proposed revision 
also more plainly lays out the requirement that the regulated person 
must be engaged in a transaction with one of the specified chemicals or 
controlled substance and use or attempt to use the U.S. Postal Service 
or any private or commercial carrier for both activities in order to be 
required to file the monthly report. This revision is not intended to 
impose any different requirements than the current regulation, but only 
to ease understanding of the reporting requirements. 21 CFR 1310.05(e) 
would correspondingly be amended to reflect the implementation of the 
mandatory electronic filing requirement.
    The DEA is also proposing technical amendments to Sec.  1310.05(d) 
to revise the mailing information in the second sentence and to replace 
the term ``shall'' in three locations without changing the 
requirements.
b. Listed Chemicals and Tableting and Encapsulating Machines
    The DEA proposes to amend Sec.  1310.05 to require reports of 
unusual or excessive loss or disappearance of a listed chemical to be 
filed through the DEA Office of Diversion Control secure network 
application. When determining whether a loss is unusual or excessive, 
the DEA is proposing guidelines that the regulated person should 
consider: (1) The actual quantity of a listed chemical; (2) the 
specific listed chemical involved; (3) whether the loss or 
disappearance of the listed chemical can be associated with access to 
those listed chemical by specific individuals, or whether the loss or 
disappearance can be attributed to unique activities that may take 
place involving the listed chemical; and (4) a pattern of losses or 
disappearances over

[[Page 63593]]

a specific time period, whether the losses or disappearances appear to 
be random, and the result of efforts taken to resolve the losses. If 
known, the regulated person would also need to report whether (1) the 
specific listed chemical was a likely candidate for diversion and (2) 
local trends and other indicators of the diversion potential of the 
listed chemical. This language is similar to the current regulatory 
language relating to theft and loss of controlled substances in Sec.  
1301.74(c).
    In addition, the DEA proposes to clarify in the revised Sec.  
1310.05(b)(1) that regulated persons must submit a report of unusual or 
excessive loss or disappearance whether or not the listed chemical is 
subsequently recovered. The DEA also has proposed changes in the 
revised Sec.  1310.05(b)(1) to clarify which party has the 
responsibility for reporting during domestic and international 
transactions. These changes will streamline the data collection process 
and allow the DEA to more efficiently respond to diversion as well as 
to respond to reporting requests concerning these items from the United 
Nations.
    The DEA also proposes to remove the phrase ``whenever possible'' 
from the oral reporting requirements of the current Sec.  1310.05(b). 
The DEA believes that the phrase is redundant with the stated 
requirement that such reports be made ``at the earliest practicable 
opportunity.'' Removing this phrase would better align the reporting 
requirements with the statutory language of 21 U.S.C. 830(b)(1).
    In response to the above discussed changes, the DEA proposes to 
restructure Sec.  1310.05(a) and (b) to reflect the revised reporting 
structure. Paragraph (a) would address those reports made solely to the 
local DEA office in accordance with the current and revised Sec.  
1310.05(a)(1) and (2). Paragraph (b) would address those reports made 
orally to the local DEA office with written reports being submitted 
through the DEA Office of Diversion Control secure network application. 
The reporting requirements now located in Sec.  1310.05(b) would be 
transferred to paragraphs (a)(1) and (2), and (b)(1) and (2), as 
applicable. This change consolidates the reporting requirements for 
each of the applicable reports into their applicable paragraphs; 
readers would no longer be required to look at both paragraphs to 
determine when and how they must initially report these transactions. 
In addition, the DEA proposes to clarify in Sec.  1310.05(a)(2) that 
regulated persons must report orally, not in writing, any proposed 
regulated transaction with a person whose description or other 
identifying characteristic the Administration has provided to the 
regulated person. Regulated persons would be required to orally report 
the other types of actions at the earliest practicable opportunity to 
the Special Agent in Charge of the DEA Divisional Office for the area 
in which the regulated person making the report is located.
    21 CFR 1310.06 would be revised to reflect the various changes in 
Sec. Sec.  1310.03 through 1310.05. Cross-citations have been amended 
to reflect where regulations have been moved and new forms instituted. 
The DEA also proposes in Sec.  1310.06(a)(3) to require regulated 
persons to include the NDC number of the product containing the listed 
chemical, if applicable, in all records required by Sec.  1310.03(a). 
If the record contains the NDC number, information about the ``form of 
packaging'' would not be necessary. The restructuring of Sec.  
1310.05(a) also corrects a long-standing typographical error in the 
current Sec.  1310.06(c), which now incorrectly references Sec.  
1310.05(a)(4) instead of (a)(3). 21 CFR 1310.06(c) currently states 
that a report submitted pursuant to Sec.  1310.05(a)(4), domestic 
regulated transactions, must include a description of the circumstances 
leading the regulated person to make the report. However, the 
corresponding example relates to an unusual loss, which is addressed in 
the current Sec.  1310.05(a)(3) (proposed Sec.  1310.05(b)(1)). The DEA 
also is proposing to make technical amendments in Sec.  1310.06, 
including replacing the term ``shall'' in paragraphs (a) and (b).
    The DEA would standardize submissions of domestic and import and 
export regulated transaction reports involving tableting and 
encapsulating machines through the introduction of a new form, the DEA 
Form 452. Under the current regulations, regulated persons who engage 
in a domestic regulated transaction in a tableting or encapsulating 
machine are required, whenever possible, to make an oral report to the 
DEA Divisional Office in advance of the transaction, followed by a 
written report. 21 CFR 1310.05 (a)(4) and (b). In the revised Sec.  
1310.05(b)(2), the DEA proposes to make the oral reporting mandatory 
and to mandate the electronic filing of the written report. The DEA 
also proposes to provide specific guidelines on when those reports must 
be given. The revised Sec.  1310.05(b)(2) would require regulated 
persons to orally report domestic regulated transactions in a tableting 
machine or an encapsulating machine when an order is placed rather than 
at the earliest practicable opportunity after the regulated person 
becomes aware of the circumstances involved. The written report (DEA 
Form 452) would be required to be filed within 15 calendar days after 
the order has been shipped by the seller. The previous standard was 
originally adopted for reporting of domestic regulated transactions for 
uniformity with the timeframe reporting standard imposed by 21 U.S.C. 
830(b)(1)(A) for transactions involving an extraordinary quantity of a 
listed chemical, an uncommon method of payment or delivery, or other 
suspicious circumstances. However, the DEA proposes to exercise its 
authority under 21 U.S.C. 830(b)(1) to impose a different reporting 
timeframe standard for machines. The revised standards are not only 
less ambiguous for regulated persons to follow, they also ensure the 
DEA receives the information in time to take appropriate action as may 
be necessary. The new DEA Form 452, which was discussed above in 
section II, A, 1, d, would cover not only import and export regulated 
transactions of tableting and encapsulating machines required under the 
current Sec.  1310.05(c) but also the domestic regulated transactions 
of tableting machines or encapsulating machines required by the current 
Sec.  1310.05(a)(4). The requirements for the content of domestic 
reports would be moved from Sec.  1310.06(d) to a new Sec.  1310.06(f), 
while the requirements for reports of importations and exportations 
would all be contained within Sec.  1310.06(e). The DEA also is 
proposing to amend the recordkeeping requirements in Sec.  1310.06(a) 
and reporting requirements in Sec.  1310.06(e) and (f) to require the 
inclusion of information about whether the machine is manual or 
electric. Under the proposed language in Sec. Sec.  1310.06(e)(1)(vi) 
and 1310.06(f)(3), the DEA would require reports of importations and 
domestic transactions to include any proposed changes to the 
identifying information of imported machines that will occur after the 
importation or other transaction.
    The DEA also is proposing to amend Sec.  1310.06 to require 
regulated persons who import or export a tableting or encapsulating 
machine to report return information to the Administration within 30 
calendar days of the release of the shipment by customs at the port of 
entry or port of export, or within 10 calendar days after receipt of a 
written request by the Administration. The DEA has included the 
provision for the requirement to submit return information earlier than 
the 30 days for two reasons. First, it conforms to the changes proposed 
for controlled

[[Page 63594]]

substances and listed chemicals in parts 1312 and 1313. Uniformity of 
requirements should simplify procedures and ease understanding of the 
requirements by regulated industry. Second, the option to request 
advance return information allows the DEA to receive information that 
may be needed for time-sensitive requirements, such as investigations 
that may need to result in immediate action to protect the public 
health and safety. Return information would be required to be submitted 
electronically through the DEA Office of Diversion Control secure 
network application on the DEA Form 452. Reports would not be deemed 
filed until a transaction identification number has been issued by the 
DEA. Pursuant to the proposed Sec.  1310.06(h), importers would be 
required to report specifics on their return, including dates of the 
transaction, quantities of machines involved, and descriptions of the 
machines. Consistent with the current requirements importers also would 
be required to report subsequent transfers of the machines under Sec.  
1310.05(b)(2). Reports of transfers after import may be submitted with 
the return information or separately.
    The proposed revisions relating to tableting and encapsulating 
machines that would standardize the submission of reports of regulated 
transactions, whether domestic or import/export, and require return 
information, would enhance the monitoring of these machines and allow 
the DEA greater ability to detect and prevent their use for the illicit 
manufacture of controlled substances. While tableting machines and 
encapsulating machines are commonly used by legitimate companies to 
produce pharmaceuticals and nutritional supplements, they are also used 
by traffickers to produce single dosage units of illicit synthetic 
substances such as methylenedioxymethamphetamine (``MDMA'') aka 
``Molly,'' ``ecstasy,'' and other synthetic designer drugs classified 
as schedule I controlled substances or analogue substances. These 
machines have also been known to be used by marijuana dispensaries, 
steroid labs, and counterfeit drug manufacturers.
    Manual capsule fillers and small encapsulating machines can produce 
anywhere from 15 to 1,000 capsules at a time, and rotary presses can 
produce massive amounts of tablets in a very short period of time. The 
value of the machines can range anywhere from under $100 to over 
$400,000 depending on the type of machine. Importers and exporters are 
not required to report the value of the machine or its production 
capacity to the DEA. However, sometimes the manifest will contain the 
weight of the shipment and will provide some indication of the 
machine's capacity.
    During 2014, 33 machines at various points of entry were seized by 
CBP for mislabeling and nonidentification. Regulatory changes in the 
proposed rule would require importers and exporters to report to the 
DEA when a shipment has been denied release by a customs officer for 
any reason, whether or not the denial was based on a violation of DEA 
regulations. Likewise, by unifying the reporting format for regulated 
transactions in tableting machines, whether domestic, import, or 
export, the DEA will be able to monitor the flow of these machines 
through the distribution chain. This will allow the DEA to better 
understand and monitor the trade in these machines and to adopt more 
efficient means of stopping the diversion of tableting and 
encapsulating machines, and prevent their use in the illicit 
manufacture of controlled substances.
7. Part 1312: Importation and Exportation of Controlled Substances
    The DEA proposes to make a technical change to Sec. Sec.  1312.11 
and 1312.22 to insert a cross-reference to part 1301 of chapter II of 
title 21 of the Code of Federal Regulations when referencing the 
registration requirements for the importation of controlled substances.
    The DEA proposes to amend Sec.  1312.14 to account for revised 
distribution procedures for import permits. The DEA is retaining the 
requirement that an official record of the permit (a ``copy'' under 
current DEA regulatory terms) accompany the shipment of controlled 
substances. This is an important tool utilized by the DEA for ensuring 
compliance with the closed system of distribution by allowing quick 
initial visual indication of compliance with requirements with the CSA. 
However, because customs officers will be able to electronically 
validate the legitimacy of the import permit through ITDS, customs 
officers will not need to physically detach the official record of the 
permit for validation. An official record of the permit must instead 
accompany the shipment until it reaches its final destination. The DEA 
also proposes to amend Sec.  1312.14 to omit the discussion of the 
circumstances in which customs officers will refuse entry of a 
shipment.
    The final destination for an import must be the registered location 
of the importer. (The import must be received at the registered address 
of the importer before being moved to another location of the importer 
or delivered to a customer.) The receipt of imported goods is a 
principal activity of registered importers. Pursuant to 21 U.S.C. 
958(h), a separate registration is required at each principal place of 
business where applicants import or export controlled substances. 
Accordingly, the final destination of a shipment of imported controlled 
substances is the registered location of the registrant. Drop 
shipments, i.e., deliveries made by an importer directly to a customer 
without passing through the registered location of the importer,\12\ 
are explicitly prohibited under the proposed revisions to Sec.  
1312.19. Similarly, consistent with current requirements, deliveries 
may not be made directly to a warehouse exempted from registration 
pursuant to Sec.  1301.12(b)(1); they must arrive first at the 
registered location.
---------------------------------------------------------------------------

    \12\ See definition of ``drop shipment,'' e.g., https://www.businessdictionary.com (accessed 05.24.2015).
---------------------------------------------------------------------------

    A technical amendment to paragraph (a) of Sec.  1312.15 is proposed 
to cross-reference Sec.  1312.16, concerning shipments that may be in 
greater or lesser amount than what is authorized by the import permit.
    Associated with the foregoing changes, as discussed earlier in this 
document, the DEA is additionally proposing to amend its regulations 
regarding expiration dates associated with imports and exports of 
controlled substances. The DEA proposes to change the current 
expiration period of import and export permits found in Sec. Sec.  
1312.16 and 1312.25 from not more than six months to not more than 180 
calendar days after the date of issuance. This change will standardize 
expiration procedures as not all months have the same number of days. 
The DEA also proposes to amend Sec. Sec.  1312.18 and 1312.27 to 
specify an expiration date for import and export declarations for 
controlled substances. Such declarations do not currently have an 
expiration date assigned to them; however, permits to import and export 
controlled substances expire not more than six months after approved 
under the current regulation. 21 CFR 1312.16 and 1312.25. Similar to 
permits, at times declarations filed with the DEA are never actually 
utilized. The DEA is concerned that absence of an expiration date for 
these declarations may lead to incomplete or inaccurate records in the 
ITDS. Therefore, the DEA is proposing that declarations expire 180 
calendar days after the date the declaration is deemed filed with the 
Administration.
    The DEA proposes to modify the condition currently found in Sec.  
1312.22(a) that requires an application

[[Page 63595]]

for a permit to export controlled substances to contain an affidavit 
that the packages of controlled substances for export are labeled in 
conformance with obligations of the United States under international 
treaties, conventions, or protocols ``in effect on May 1, 1971.'' The 
regulation will be amended to instead require that such affidavit state 
that packages of controlled substances for export are labeled in 
conformance with obligations of the United States under international 
treaties, conventions, or protocols which are in effect at the time of 
export or reexport. The DEA does not believe that this change will have 
any current effect on the regulated community because it is not a new 
requirement. However, the DEA is taking this opportunity in revising 
its other import and export regulations to propose this change to 
account for any changes in international treaties, conventions, or 
protocols which might be made in the future.
    As discussed above, this proposal includes changes to harmonize, to 
the extent possible, return information requirements for import and 
export regulations throughout parts 1310, 1312, and 1313 for tableting 
and encapsulating machines, controlled substances, and listed 
chemicals. Although these provisions are similarly structured, the 
actual content of the return information varies across the regulations 
to account for international reporting requirements for machines, 
controlled substances, and listed chemicals. Variations in return 
reporting requirements also vary among controlled substances, listed 
chemicals, and tableting and encapsulating machines to maximize the 
detection, investigation, and prevention of diversion. The DEA has 
reviewed the return information currently collected for imported and 
exported controlled substances and is proposing changes.
    The DEA is proposing amendments to Sec. Sec.  1312.12, 1312.18, 
1312.22, and 1312.27 to require registrants and those exempt from 
registration to report return information to the Administration 
following imports and exports of controlled substances authorized by 
permits and conducted pursuant to filed declarations. The DEA is 
proposing to require this information to be submitted within 30 
calendar days, or within 10 calendar days after a request from the 
Administration, whichever is sooner. This regulatory text change is 
consistent with existing business practice, as importers and exporters 
generally submit such information to the DEA at the conclusion of 
transactions. The submission of such reports will allow the United 
States to meet its obligations under article 19 (Estimates of drug 
requirements) and article 20 (Statistical returns to be furnished to 
the Board) of the Single Convention on Narcotic Drugs, 1961, and 
article 16 (Reports to be furnished by the Parties) of the Convention 
on Psychotropic Substances, 1971. The DEA will continue to 
independently collect such return information outside of the single 
window as the ITDS does not capture all elements of the return 
information that the DEA needs to submit under those treaty obligations 
and otherwise adequately monitor the closed system of distribution of 
imports and exports to detect and prevent diversion. 21 U.S.C. 871(b). 
Additionally, the timing and frequency of required return information 
reporting is outside the scope of the single window. Requirements for 
return information to be submitted to the DEA are already specifically 
included in Sec.  1312.22(d)(6) for reexported controlled substances 
pursuant to 21 U.S.C. 953(f)(6).
    For imported and exported controlled substances there are four 
principal pieces of information that the DEA is proposing importers and 
exporters supply to the DEA in the returns: The date on which the 
controlled substances arrived/departed the registered location, the 
date on which a customs officer released the shipment, the actual 
quantity of controlled substances that arrived/left the registered 
location, and the actual quantity of controlled substances that a 
customs officer actually released. The current text in 21 CFR 1312.22 
relating to controlled substances exported for subsequent reexportation 
requires the reporting of the ``date shipped.'' This requirement has 
been interpreted differently, sometimes as the date it left the 
facility and sometimes as the date the import/export transaction 
occurred. Both dates are needed to adequately monitor the closed system 
of distribution for import and export transactions. For example, an 
analysis of the amount of time it takes a shipment to complete an 
import or export transaction could be compared with the rate of theft 
and loss and could potentially lead to corresponding changes to DEA 
security regulations being proposed. Likewise both the actual amount of 
controlled substances that customs released and the actual amount of 
controlled substances that arrived or left the registered facility are 
needed to adequately monitor the closed system of distribution and 
allow precise accountability of all substances within a registrant's 
inventory. These figures allow a base level against which to cross-
check reports for in-transit losses for imported and exported 
controlled substances.
    The DEA proposes to revise Sec. Sec.  1312.12, 1312.18, 1312.22, 
and 1312.27 to prohibit the importation/exportation of any shipment of 
controlled substances denied release by customs at the port of entry or 
port of export for any reason without resubmission of the permit 
application or declaration and issuance of a new permit or transaction 
identification number by the DEA. For example, if a customs officer 
denied release of controlled substances at the port of entry because of 
a violation of another agency's regulation (e.g., U.S. Food and Drug 
Administration), customs officials would not allow entry until after 
the reason for denial was adequately addressed and the DEA has issued a 
new permit or transaction identification number. This change is needed 
to strengthen the DEA's ability to monitor and detect practices that 
may render an importer's or exporter's registration inconsistent with 
the public safety, especially in relation to the DEA's statutory 
obligation to take into consideration an applicant's compliance with 
applicable State and local laws and other relevant factors. 21 U.S.C. 
823(a), 958(a).
    The DEA proposes to amend Sec.  1312.22 to reflect that the 
Administration has discretion whether to issue a permit for reexport 
pursuant to 21 U.S.C. 953(f). The proposed revision to Sec.  
1312.22(g)(8), like the current regulation, specifies that the exporter 
must provide ``a brief summary of the facts that warrant the return'' 
of an export that has been refused or is otherwise unacceptable or 
undeliverable. The DEA Office of Diversion Control secure network 
application contains a field appropriate for this information within 
the DEA Form 357. Likewise, the ``written request for reexport'' of a 
controlled substance subject to declaration requirements, currently 
required in Sec.  1312.27(b)(5)(iv), can be submitted in a field of the 
DEA Form 236 in the DEA Office of Diversion Control secure network 
application. As in the current regulations, a refused or otherwise 
unacceptable or undeliverable controlled substance subject to the 
declaration requirements could be imported only after the DEA issues 
``affirmative authorization in writing.'' A transaction identification 
number does not serve as such ``affirmative authorization in writing.''
    The DEA proposes to amend Sec. Sec.  1312.22, 1312.31, and 1312.32 
to require a certified translation of

[[Page 63596]]

authorizations issued by foreign competent national authorities that 
are not issued either entirely in English or bilingual with English. If 
the foreign authorization, or the certified copy of such, is not 
written in English or bilingual with another language and English, the 
registrant must submit with their application or notice a certified 
translation of the permit or license. The DEA proposes that for 
purposes of this requirement, certified translation will mean that the 
translator has signed the translation legally attesting to the accuracy 
of the translation and the attestation has been notarized. This change 
is meant to ensure that these foreign authorizations are complete and 
accurate, and that the information that they contain are accurately 
understood and applied to DEA import/export policies and procedures.
8. Reexportation of Controlled Substances--Including Implementation of 
Section 4 of the Improving Regulatory Transparency for New Medical 
Therapies Act
    This proposal contains amendments that would implement section 4, 
Re-exportation Among Members of the European Economic Area, of the 
Improving Regulatory Transparency for New Medical Therapies Act, Public 
Law 114-89 (hereinafter ``the 2015 Act''), which was signed into law on 
November 25, 2015. Section 4 of the 2015 Act amended section 1003 of 
the Controlled Substances Import and Export Act (CSIEA) (21 U.S.C. 953) 
by making changes to paragraph (f) and adding paragraph (g), changes 
that allow for expanded reexportation of certain controlled substances 
among members of the European Economic Area (EEA). Prior to passage of 
the 2015 Act, the CSIEA (21 U.S.C. 953(f)) provided, with respect to 
controlled substances in schedule I or II and narcotic drugs in 
schedule III or IV, that such substances could be exported from the 
United States for subsequent reexport from the recipient country (the 
``first country'') to another country (the ``second country'')--but 
with no further reexports from the second country. The 2015 Act removed 
this latter limitation provided that every country involved is an EEA 
country. As a result, unlimited further reexports may now occur among 
EEA countries, provided the conditions specified in the 2015 Act are 
met.
    Beyond the new allowance for unlimited reexports among EEA 
countries, most of the statutory requirements that applied to all 
reexports prior to the 2015 Act remain in effect under the 2015 Act 
with respect to reexports among EEA countries. For example, it remains 
a requirement that first, second, and subsequent countries within the 
EEA must be parties to the Single Convention on Narcotic Drugs, 1961, 
and the Convention on Psychotropic Substances, 1971. 21 U.S.C. 
953(f)(1). Also consistent with pre-enactment statutory requirements, 
each such EEA country must have instituted and maintain, in conformity 
with such Conventions, a system of controls of imports which the 
Attorney General deems adequate, the importer and exporter must be 
properly permitted or licensed, and the controlled substance must be 
applied exclusively to medical, scientific, or other legitimate uses. 
21 U.S.C. 953(f)(2).
    However, in contrast to the reexport requirements that apply where 
the reexport involves any non-EEA countries, the 2015 Act provides that 
reexportation from the first EEA country to a second EEA country may 
not be constrained to any specific time period. 21 U.S.C. 953(g)(1). 
This notice proposes revisions to DEA regulations to incorporate this 
and other changes mandated by the 2015 Act.
    In drafting the proposed regulatory changes to implement the 
statutory changes made by the 2015 Act, the DEA carefully took into 
consideration the new subsection, 21 U.S.C. 953(g)(2), which prohibits 
the Attorney General from promulgating or enforcing any regulation, 
subregulatory guidance, or enforcement policy which impedes re-
exportation of any controlled substance among European Economic Area 
countries, including by promulgating or enforcing any requirement that 
information concerning the consignee, country, and product be provided 
prior to exportation of the controlled substance from the United States 
or prior to each re-exportation among members of the European Economic 
Area.
    In interpreting the foregoing provision of the 2015 Act, given that 
the term ``impedes'' is somewhat vague, the DEA took the following 
factors into account. First, the CSIEA itself continues to impose 
various requirements that some might characterize as ``impeding'' 
reexports among EEA countries. Specifically, as described above, the 
2015 Act retained, with respect to such reexports, most of the 
preexisting requirements in 21 U.S.C. 953(f). Second, for the United 
States to continue to meet its reporting and other obligations under 
the Single Convention and Psychotropic Convention, the DEA must 
continue to obtain certain information from persons involved in 
reexport transactions. For these reasons, the DEA does not interpret 
the term ``impedes'' in the 2015 Act to prohibit the DEA from imposing 
any requirement that goes beyond the explicit requirements of 21 U.S.C. 
953(f) and (g). Rather, the DEA interprets the ``impedes'' clause as 
follows: (i) The DEA may not promulgate or enforce any regulation of 
the specific nature described in paragraphs (1) and (2) of 21 U.S.C. 
953(g) and (ii) beyond the type of restrictions referred to in 
paragraphs (1) and (2), the DEA must avoid promulgating or enforcing 
any unduly burdensome regulations on such reexports.
    Consistent with the foregoing interpretation of the 2015 Act, in 
the proposed revised regulations, the DEA would no longer require bulk 
substances to undergo further manufacturing process within the first 
EEA country if the substance is to be reexported within the EEA. Also 
consistent with this interpretation of the 2015 Act, the DEA proposes 
to remove the requirement that the exporter must provide product and 
consignee information beyond the first country in advance of (prior to) 
export from the United States. Exporters who submit an application for 
reexport among members of the EEA will continue to be required to 
supply information of the consignee in the first country, including the 
consignee's contact information and business--but (as mandated by the 
2015 Act) information concerning the second or subsequent consignee, 
country, and product will not be required to be provided prior to 
exportation of the controlled substance from the United States or prior 
to each reexportation among members of the EEA. The DEA's continued 
collection of this information will help ensure that the DEA has 
sufficient information to uphold U.S. treaty obligations.
    Also consistent with the retained requirements of 21 U.S.C. 953(f), 
DEA registered exporters seeking to export controlled substances to the 
EEA for such reexport will continue to be required to submit an 
affidavit that the consignee in the second country and any country of 
subsequent reexport within the EEA is authorized under the laws and 
regulations of the recipient country to receive the controlled 
substances, that the packages are labeled in conformance with U.S. 
treaty obligations that the controlled substances are to be applied 
exclusively for medical or scientific uses, that the controlled 
substances will not be reexported outside of the EEA, and that there is 
an actual need for the controlled substances for medical or scientific 
uses within the recipient country. Consistent

[[Page 63597]]

with past practice, this affidavit will constitute ``substantial 
evidence'' for purposes of 21 U.S.C. 953(f)(4) for reexports of 
controlled substances among members of the European Economic Area. See 
71 FR 61436, 61438, Oct. 18, 2006.
    Presently, under the current Sec.  1312.22(d)(7), the DEA requires 
that controlled substances must be reexported from the first country to 
the second country, or countries, within 180 days after the controlled 
substances have been exported from the United States. As discussed in 
the notice of proposed rulemaking for Reexportation of Controlled 
Substances, for which the associated final rule added this provision to 
Sec.  1312.22, the justification behind this requirement is to minimize 
the likelihood of uncertainties regarding the status of reexport 
shipments and thereby minimize the likelihood of diversion. 71 FR 
61436, 61437, Oct. 18, 2006. However, as previously stated above, the 
2015 Act specifically provides that reexportation among members of the 
EEA may not be constrained to any specific time period. 21 U.S.C. 
953(g)(1). Therefore, the DEA proposes to eliminate application of this 
provision to reexports of controlled substances among members of the 
EEA.
    While, as just discussed, the DEA is proposing to eliminate certain 
requirements for EEA reexports in order to bring DEA regulations into 
accordance with the 2015 Act, the DEA continues to believe that those 
requirements serve an important purpose in safeguarding against 
international diversion and promoting compliance with international 
treaty obligations. Therefore, the DEA is not proposing to change or 
exclude those requirements as they apply outside of the EEA reexport 
context, as Congress did not require the DEA to do so.
    Persons who export controlled substances for reexport among members 
of the EEA are required by the law to provide return information to the 
Attorney General within 30 days after each re-exportation, including 
certification that the reexportation has occurred and ``information 
concerning the consignee, country, and product.'' 21 U.S.C. 
953(f)(6)(B). This return information is in addition to the return 
information that the exporter must provide related to the export of the 
controlled substance from the United States to the first country. 
Because of the constraints imposed by the statutory language in the 
2015 Act, the DEA is proposing a straightforward 30-calendar-day 
reporting limit for reexports of controlled substances without the 
caveat that the Administration may request such information sooner, as 
is generally contained in this proposal for other return information. 
Although the DEA is without authority to require such information to be 
submitted in advance of the 30-day statutory deadline, the DEA 
continues to encourage return information on reexports to be submitted 
as soon as possible so as to allow the DEA to meet its treaty reporting 
deadlines.\13\
---------------------------------------------------------------------------

    \13\ ``Under the Single Convention, each country that is a party 
to the treaty is required to furnish the International Narcotics 
Control Board (INCB) with annual estimates of, among other things, 
the quantities of narcotic drugs on hand, the anticipated amounts 
that will be consumed by the party for legitimate purposes, and the 
anticipated production quantities. The Single Convention also 
requires parties to furnish the INCB with statistical returns for 
the prior year, indicating the amounts of drugs produced, utilized, 
consumed, imported, exported, seized, disposed of, and in stock. The 
Psychotropic Convention requires the parties to provide the INCB 
with statistical reports and assessments containing similar 
information with respect to psychotropic substances. Through the 
collection of this information, the INCB provides exporting 
countries with information on the legitimate requirements of the 
importing countries and can take steps to reduce the likelihood of 
international diversion.'' 71 FR 61436, 61438, Oct. 18, 2006.
---------------------------------------------------------------------------

    To effectuate and efficiently implement the different reexport 
requirements between those controlled substances intended for reexport 
outside the EEA and those intended for reexport within the EEA, the DEA 
is proposing to restructure Sec.  1312.22. The DEA proposes to 
restructure Sec.  1312.22 to generally align with the three types of 
exports covered by the regulation--export not for reexport, export for 
reexport outside of the EEA, and export for reexport within the EEA. 
The requirements for export/reexport and return information would be 
addressed separately under the corresponding header for each type of 
transaction. Of particular note, this reorganization would allow 
readers to easily understand the return reporting information for each 
type of transaction: Return on an export from the United States (not 
for reexport); for reexports outside the EEA--the return on the initial 
export from the United States to the first country and a return on the 
export from the first country to the second country; and for reexports 
among members of the EEA--the return on the initial export from the 
United States to the first country and return on the export from the 
first country to the second country/subsequent export(s) to other EEA 
member countries.
    The DEA is proposing to establish a new Form 161R-EEA for the 
reporting of reexports among members of the EEA. The DEA Form 161R-EEA 
would be accessed, completed, and submitted through the DEA Office of 
Diversion Control secure network application. The DEA considered, but 
ultimately did not choose to propose, that such applications would be 
made electronically on the DEA Form 161R based on the fact that there 
are different application requirements for the two types of 
transactions required by the CSA. Most important of these distinctions 
for tracking purposes are that reexports among members of the European 
Economic Area do not have a time period for which such transactions 
will ``close'' (i.e., all return information submitted). While under 
current Sec.  1312.22(d)(7) (proposed Sec.  1312.22(h)(6)), other 
reexports must be completed no later than 180 days after initial export 
from the United States, the 2015 Act specifies that controlled 
substances may continue to be reexported within the European Economic 
Area indefinitely, so long as the statutory conditions are met. Use of 
a new form should not impose a burden on registrants, however. Because 
the system is electronic the experience for the registrant will be the 
same regardless of whether they are entering the required application 
information on a new electronic form or being redirected to a different 
portion of the electronic DEA Form 161R.
    While the new law did not have a direct impact on reexports for 
nonnarcotic controlled substances in schedules III and IV or controlled 
substances in schedule V, the DEA is proposing to make corresponding 
changes to its reexport of controlled substances under declaration 
procedures found in Sec.  1312.27. If such conforming amendments were 
not made, there would be stricter requirements for controlled 
substances exported for reexport within the European Economic Area 
under declaration procedures than under permit procedures. See also DEA 
final rule, Registration of Manufacturers, Distributors, and Dispensers 
of Controlled Substances; Registration of Importers and Exporters of 
Controlled Substances; Importation and Exportation of Controlled 
Substances; updating Requirements, 52 FR 17286, 17287, May 7, 1987 
(``One of the stated purposes for the Diversion Control Amendments is 
to decrease the disparity of control between narcotic and non-narcotic 
controlled substances.'').

[[Page 63598]]

9. Part 1313: Importation and Exportation of List I and List II 
Chemicals
    The DEA proposes to add a new Sec.  1313.03 that would consolidate 
the DEA Form information applicable to part 1313 in a corresponding 
change to that proposed for the new Sec.  1312.03. The new Sec.  
1313.03 would consist of a table referencing the DEA Form number, form 
name, information about where the form may be accessed, and where the 
completed form should be submitted.
    The DEA proposes to amend Sec.  1313.12(b) to require that all 
declarations (DEA Form 486/486A) must be complete and accurate when 
submitted. Under Sec.  1304.21, registrants must maintain complete and 
accurate records for controlled substances. That requirement applies to 
import and export declarations for controlled substances. This proposed 
revision would impose the same requirement for import/export 
declarations as for listed chemicals.
    Declarations (DEA Forms 486/486A) would not be deemed filed until 
the transaction identification number has been issued by the DEA. Upon 
receipt and review, the DEA would assign each declaration a transaction 
identification number (a unique identifier). Once the declaration has 
been accepted and assigned a transaction identification number, 
registrants would be able to use the assigned transaction 
identification number to access the official record of the declaration. 
While current DEA regulations do not require confirmation of receipt 
from the DEA prior to importation or exportation pursuant to a 
declaration, the proposed change is consistent with current practices. 
Currently, the DEA assigns a Web Tracking Number to each declaration 
when it is submitted and accepted. The proposed regulatory codification 
of the issuance of a transaction identification number is designed to 
ensure that electronically submitted declarations are indeed received 
by the DEA, are completed, and can be appropriately tracked and 
monitored; to streamline the declaration filing process; and to 
eliminate duplicate filings. The fact that the DEA issues a transaction 
identification number after reviewing the filing does not waive the 
Administration's right to suspend a shipment under Sec.  1313.41.
    The DEA is proposing to make changes in the regulatory text to 
reflect that 21 U.S.C. 830 has been changed to require official records 
of import declarations involving listed chemicals to be retained for 
two years.
    As discussed above, return information requirements have been 
harmonized across parts 1310, 1312, and 1313, to the extent possible. 
The DEA is proposing that return information must be reported within 30 
calendar days after release by a customs officer at the port of entry 
or export, or reexport. All return information for applications or 
other initial filings that are required to be made electronically 
through the DEA Office of Diversion Control secure network application 
would likewise be required to be filed electronically through the same 
system. As with controlled substance return information, the DEA is 
proposing to require listed chemical importers and exporters to include 
both the date a customs officer releases an imported item or releases 
an item for export and the date that the shipment arrived at the 
location of the importer or exporter, the actual quantities of product 
both when released by a customs officer and at the time of shipment 
from the exporter's location or arrival at the importer's location, and 
the actual port of entry or export. These revised reporting 
requirements will better allow the DEA to track the flow of listed 
chemicals, and detect and prevent diversion. For example, by tracking 
and comparing diversion of listed chemicals against the actual port of 
entry or exit, the DEA will be better able to detect potential weak 
spots in the import/export system and direct more resources to that 
region. The DEA also is proposing to revise the regulatory text to 
clarify that the references to ``chemical'' and ``container'' apply to 
the reporting of subsequent transfers.
    The final destination for an import of a list I chemical must be 
the registered location of the registered importer. The import must be 
received at the registered address of the importer before being moved 
to another location of the importer or delivered to a customer. The 
receipt of imported goods is a principal activity of registered list I 
chemical importers. Pursuant to 21 U.S.C. 958(h), a separate 
registration is required at each principal place of business where 
applicants import or export list I chemicals. Accordingly, the final 
destination of a shipment of an imported list I chemical is the 
registered location of the registrant. Drop shipments, i.e., deliveries 
made by an importer directly to a customer without passing through the 
registered location of the importer,\14\ are explicitly prohibited 
under the proposed revisions to Sec.  1313.14. Similarly, consistent 
with current requirements, deliveries may not be made directly to a 
warehouse exempted from registration pursuant to Sec.  1309.23(b)(1); 
they must arrive first at the registered location.
---------------------------------------------------------------------------

    \14\ See definition of ``drop shipment'', e.g., https://www.businessdictionary.com (accessed 05.24.2015).
---------------------------------------------------------------------------

    The DEA is proposing to amend Sec.  1313.22(a) to add a cross-
reference to Sec.  1310.04(g) relating to listed chemicals that may be 
exported. This change would harmonize Sec.  1313.22(a) with Sec.  
1313.21(a).
10. Part 1316: Administrative Functions, Practices, and Procedures
    The DEA proposes to amend Sec.  1316.47(a) to align with the DEA's 
current practice referenced in all recent Federal Register publications 
that requests for a hearing are to be sent directly to the Hearing 
Clerk. Specifically, this amendment would remove ``Attention: DEA 
Federal Register Representative'' from the template letter. Since the 
paragraph before the template letter states that persons requesting a 
hearing should refer to Sec.  1321.01 for current mailing addresses, 
the DEA is not adding an ``Attention'' field in the template letter.
    The DEA is proposing to amend Sec.  1316.48 so that the filing of 
notices of appearance corresponds with the DEA's practice that requests 
for hearing shall be sent to the Hearing Clerk. Specifically, the DEA 
would remove ``Attention: Federal Register Representative'' from the 
template letter. Since the paragraph before the template letter states 
that persons requesting a hearing should see Sec.  1321.01 for current 
mailing addresses, the DEA is not adding an ``Attention'' field in the 
template letter.

C. DEA Mailing Addresses

    The DEA proposes to amend the Table of DEA Mailing Addresses found 
in Sec.  1321.01 to account for changes proposed in this rule as part 
of the implementation of ITDS. The DEA is also taking this opportunity 
to propose various technical amendments to the Table of DEA Mailing 
Addresses.
    Pursuant to this proposed action all import and export applications 
and filings would be submitted through the DEA Office of Diversion 
Control secure network application. The DEA proposes to amend the Table 
of DEA Mailing Addresses to retain a reference to the notifications 
that, prior to this rule, could be made by mail, but note with an 
asterisk that those filings must now be made electronically. The CFR 
sections listed under the DEA Import/Export Unit would be merged with 
those under the DEA Regulatory Section and placed under the header of 
``DEA Regulatory Section.''

[[Page 63599]]

    The mailing addresses for Sec. Sec.  1308.21(a), 1308.23(b), 
1308.25(a), 1308.31(a), 1308.33(b), and 1310.13(b) will be transferred 
from the DEA Office of Diversion Control to the DEA Drug & Chemical 
Evaluation Section (ODE), the subject matter experts on excluded and 
exempted products. This change will allow these matters to be processed 
in a more efficient manner. The reference to Sec.  1307.22, ``Disposal 
of Controlled substances by the Administration delivery application,'' 
will be revised to ``Delivery of surrendered and forfeited controlled 
substances'' in conformity with the final rule, Disposal of Controlled 
Substances, 79 FR 53520, Sept. 9, 2014. Corresponding to recent 
internal DEA reorganization, the mailing addresses for Sec. Sec.  
1303.12(b), 1303.12(d), 1303.22, 1304.31(a), 1304.32(a), 1315.22, 
1315.32(e) and (g), 1315.34(d), and 1315.36(b), regarding quota 
applications and reporting, will be moved from the DEA Drug & Chemical 
Evaluation Section to the UN Reporting & Quota Section under a new 
corresponding header.
    The DEA proposes to amend Sec.  1316.48 to provide that notices of 
appearance should be sent to the DEA Hearing Clerk instead of the DEA 
Administrator so that notices of appearance will be filed in a more 
efficient manner. The DEA also proposes to amend Sec.  1316.47 to 
provide that requests for hearing should be sent to the DEA Hearing 
Clerk instead of the DEA Federal Register Representative so that such 
requests will be filed in a more efficient manner. In the Table of DEA 
Mailing Addresses in Sec.  1321.01, DEA proposes to make the 
corresponding change, and to add Sec. Sec.  1301.43, 1303.34, 1308.44, 
and 1316.47(a), regarding requests for hearing or appearance and/or 
waivers, under the DEA Hearing Clerk heading. These items are being 
directed to the DEA Hearing Clerk to expedite the hearing process and 
will lead to fewer delays. The DEA is additionally revising this 
portion of the table to correct the attention line of the mailing 
address for the DEA Hearing Clerk. The address will be changed from 
``Drug Enforcement Administration, Attn: Hearing Clerk/LJ, 8701 
Morrissette Drive, Springfield, VA 22152'' to ``Drug Enforcement 
Administration, Attn: Hearing Clerk/OALJ, 8701 Morrissette Drive, 
Springfield, VA 22152.''
    The DEA is adding the following citations to be directed to the DEA 
Federal Register Representative: Sec.  1301.34(a)--Filing of written 
comments regarding application for importation of Schedule I and II 
substances; Sec.  1303.11(c)--Filing of written comments regarding 
notice of an aggregate production quota; and Sec.  1303.13(c)--Filing 
of written comments regarding adjustments of aggregate production 
quotas. These topics have been added so that comments corresponding to 
Federal Register publications can be sent directly to the Federal 
Register Representative whose responsibility it is to review comments 
and make them publicly available, as appropriate. The DEA is 
additionally amending this portion of the table to revise the attention 
line of the mailing address for the DEA Federal Register 
Representative. The address will be changed from ``Drug Enforcement 
Administration, Attn: Federal Register Representative/ODL, 8701 
Morrissette Drive, Springfield, VA 22152'' to ``Drug Enforcement 
Administration, Attn: Federal Register Representative/ODW, 8701 
Morrissette Drive, Springfield, VA 22152.'' Additionally, this rule 
adds the Web address for the Federal eRulemaking Portal, https://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 https://www.regulations.gov or be directed to the DEA Federal Register 
Representative.

III. Regulatory Analyses

Executive Orders 12866 and 13563

    This proposed rule was developed in accordance with the principles 
of Executive Orders 12866 and 13563. The DEA has determined that this 
proposed rule is a significant regulatory action, and accordingly this 
rule has been submitted to the Office of Management and Budget for 
review.
    By business activity, the DEA estimates this rule will result in a 
combined annual savings of $424,640 for controlled substances 
importers, exporters, researchers, and analytical labs; a combined 
annual cost of $5,011 for listed chemical importers and exporters and 
tableting and encapsulating machine importers and exporters; and no 
economic impact for brokers, domestic transactions in tableting and 
encapsulating machines, and mail order transactions of ephedrine (EPH), 
pseudoephedrine (PSE), phenylpropanolamine (PPA), or gamma-
hydroxybutyric acid (GHB). Therefore, the estimated net annual impact 
of this rule is a cost savings of $419,629 and the estimated combined 
annual economic effect is $429,650. The DEA does not anticipate that 
this rulemaking will have an annual effect on the economy of $100 
million or more or adversely affect, in a material way, the economy, a 
sector of the economy, productivity, competition, jobs, the 
environment, public health or safety, or State, local, or tribal 
governments or communities. An economic analysis of the proposed rule 
can be found in the rulemaking docket at https://www.regulations.gov.

Executive Order 12988

    The proposed regulation meets the applicable standards set forth in 
sections 3(a) and 3(b)(2) of Executive Order 12988, Civil Justice 
Reform to eliminate ambiguity, minimize litigation, establish clear 
legal standards, and reduce burden.

Executive Order 13132

    This rulemaking does not have federalism implications warranting 
the application of Executive Order 13132. The rule does not have 
substantial direct effects on the States, on the relationship between 
the national government and the States, or the distribution of power 
and responsibilities among the various levels of government.

Executive Order 13175

    This proposed rule is in accordance with the February 19, 2014, 
Executive Order 13659, ``Streamlining the Export/Import Process for 
America's Businesses,'' 79 FR 10657, Feb. 25, 2014. It does not have 
substantial direct effects on the States, on the relationship between 
the national government and the States, or the distribution of power 
and responsibilities between the Federal Government and Indian tribes.

Regulatory Flexibility Act

    The Administrator, in accordance with the Regulatory Flexibility 
Act (5 U.S.C. 601-612) (RFA), has reviewed this rule and by approving 
it certifies that it will not have a significant economic impact on a 
substantial number of small entities.
    Below is a summary of the threshold analyses conducted by the DEA 
to support the certification statement above. The complete threshold 
analysis is available at https://www.regulations.gov for easy reference. 
The DEA specifically solicits written comments regarding the DEA's 
economic threshold analysis of the impact of these proposed changes. 
The

[[Page 63600]]

DEA requests that commenters provide detailed descriptions in their 
comment of any expected economic impacts, especially to small entities. 
Commenters should provide empirical data to illustrate the nature and 
scope of such impact.
    In accordance with the RFA, the DEA evaluated the impact of this 
rule on small entities. This proposed rule affects all entities who 
import or export, or seek to import or export, controlled substances, 
listed chemicals, tableting and encapsulating machines, or who broker 
international transactions (from foreign country to another foreign 
country while in the United States). Additionally, this proposed rule 
affects all persons who would be required to report unusual or 
excessive loss or disappearance of a listed chemical under the control 
of the regulated person in accordance with proposed revised Sec.  
1310.05(b)(1), all persons who are required to report domestic 
regulated transactions in tableting or encapsulating machines in 
accordance with proposed revised 21 CFR 1310.05(b)(2), and all persons 
who are required to report mail order transactions of ephedrine (EPH), 
pseudoephedrine (PSE), phenylpropanolamine (PPA), or gamma-
hydroxybutyric acid (GHB) in accordance with 21 CFR 1310.03(c). The 
affected entities include DEA registrants and non-registrants. A DEA 
registration is required to import or export any controlled substance 
and most list I chemicals. A DEA registration is not required to import 
or export some list I chemicals or any list II chemical, to import or 
export tableting and encapsulating machines, or to broker international 
transactions. Also, a DEA registration is not required to conduct 
domestic transactions in tableting and encapsulating machines or mail 
order transactions of EPH, PSE, or PPA. (Registration is required for 
mail order transactions of GHB as GHB is a schedule I controlled 
substance.) The affected entities (DEA registrants and non-registrants) 
are grouped into ``business activities,'' based on types of activities 
performed by the entities. The business activities described in this 
analysis that are required to have DEA registrations are importers/
exporters, researchers, analytical labs, and chemical importers/
exporters that deal in the list I chemicals requiring registration 
(referred to as ``DEA-registered listed chemical importers/
exporters''). The business activities described in this analysis that 
are not required to have DEA registrations are chemical importers/
exporters that deal in list I chemicals not requiring registration and 
list II chemicals (referred to as ``non-registered listed chemical 
importers/exporters''), tableting/encapsulating machine importers/
exporters, brokers of international transactions, tableting/
encapsulating machine domestic suppliers, and entities selling EPH, 
PSE, and/or PPA by mail order.
    The DEA estimates that 7,840 entities are affected by this rule, 
which consist of 331 controlled substances importers/exporters; 5,884 
researchers; 1,200 analytical labs; 231 DEA-registered listed chemical 
importers/exporters; 76 non-registered listed chemical importers/
exporter; 56 tableting/encapsulating machine importers/exporters; 12 
brokers of international transactions; 46 tableting/encapsulating 
machine domestic suppliers; and 4 entities selling EPH, PSE, PPA, and/
or GHB by mail order. Regulated persons potentially reporting unusual 
or excessive loss or disappearance of a listed chemical would be 
included in one of the business activities above.
    The DEA estimates 7,321 (93.4%) of total 7,840 affected entities 
are small entities. Specifically, the DEA examined the impact of the 
proposed changes regarding (1) mandatory electronic permit applications 
and filings, and (2) 180-calendar-day expiration for all declarations 
for the 7,321 small entities affected by the proposed rule, which 
consist of 310 controlled substances importers/exporters; 5,474 
researchers; 1,134 analytical labs; 218 DEA-registered listed chemical 
importers/exporters; 72 non-registered listed chemical importers/
exporters; 54 tableting/encapsulating machine importers/exporters; 11 
brokers of international transactions; 44 tableting/encapsulating 
machine domestic suppliers; and 4 entities selling EPH, PSE, PPA, and/
or GHB by mail order.
    The DEA is proposing to mandate the electronic submission of all 
permit applications and other required filings and reports associated 
with the importation or exportation of tableting and encapsulating 
machines, controlled substances, and listed chemicals. Additionally, 
the DEA is proposing to mandate the electronic submission of all 
reports associated with the unusual or excessive loss or disappearance 
of a listed chemical, domestic regulated transactions in tableting or 
encapsulating machines, and mail order transactions of EPH, PSE, PPA, 
and GHB. The DEA would cease to accept paper filing of controlled 
substances import/export permit applications (other than 
transshipments), controlled substances import/export declarations, 
listed chemicals import/export declarations, and certain filings and 
reports specified as discussed previously in this document. Currently, 
some electronic forms associated with these activities are available 
online and in use. Usage rates vary for each form and also vary by 
business activities. However, as virtually all paper submissions of 
permit applications and declarations are currently delivered via 
express common carrier with pre-paid return envelope or account 
information, savings are anticipated because of this change.
    The DEA estimates that each conversion to electronic filing from 
paper controlled substances import/export permit application and 
controlled substances import/export declaration will result in an 
estimated cost savings of $58.75 and $9.75, respectively. Based on 
DEA's registration data, the DEA assumes all affected entities have 
information systems capable of completing and submitting online forms 
and downloading, printing, and transmitting electronic documents at 
nominal additional cost. Among the affected establishments that hold 
DEA registrations, 92% of previous applications for registration or 
renewal of registration were made online. Furthermore, even though the 
email address is an optional data field, 99% of the registrations have 
an email address on record. Based on these facts and the high rate of 
internet penetration in the general U.S. population,\15\ it is 
reasonable to assume virtually all regulated establishments, 
registrants and non-registrants, have information systems capable of 
completing and submitting online forms and downloading, printing, and 
transmitting electronic documents at minimal additional cost. No 
special software or equipment will be needed to access the DEA Office 
of Diversion Control secure network application.
---------------------------------------------------------------------------

    \15\ See note 15 of the accompanying Economic Impact Analysis 
(``An estimated 78.1 percent of people in U.S. households had a 
high-speed Internet connection in 2013. ``Computer and Internet Use 
in the United States: 2013,'' U.S. Census Bureau, https://www.census.gov/content/dam/Census/library/publications/2014/acs/acs-28.pdf.'').
---------------------------------------------------------------------------

    There are no anticipated cost savings for the conversion to 
electronic filing from paper for the listed chemicals import/export 
declarations and tableting and encapsulating machine import/export 
notifications since virtually all are currently submitted via online, 
facsimile, or email, without the use of a common carrier. However, the 
DEA anticipates an additional cost associated

[[Page 63601]]

with the new requirement for tableting/encapsulating machine importers/
exporters to submit return information within 30 calendar days after 
the release by a customs officer has taken place or within 10 calendar 
days after receipt of a written request by the Administration to the 
exporter/importer, whichever is sooner.
    The DEA estimates there will be no economic impact associated with 
the electronic submission of all reports associated with the unusual or 
excessive loss or disappearance of a listed chemical, domestic 
regulated transactions in tableting or encapsulating machines, and mail 
order transactions of EPH, PSE, PPA, and GHB. While the written reports 
would be required to be made online, the labor cost of making the 
report is expected to be the same, whether on paper or online.
    Based on the varying number of annual occurrences estimated for 
each of the business activities, the DEA estimates importers/exporters 
as a group would save $383,857, researchers as a group would save 
$4,316, and analytical labs as a group would save $37,567. The DEA 
estimates tableting/encapsulating machine importers/exporters as a 
group would have an additional cost of $3,978, for a total net savings 
of $421,761 for the electronic submissions requirement. (Figures are 
rounded.) Based on the number of affected entities and the cost savings 
to the business activities as a group, the DEA estimated the average 
annual cost savings for each affected entity. The DEA estimates 
importers/exporters, researchers, and analytical labs will save on 
average $1,160, $1, and $31 per year, respectively, and tableting/
encapsulating machine importers/exporters would have a cost of $71 per 
year.
    In addition, the DEA is proposing to specify that all controlled 
substance and listed chemical declarations expire in 180 calendar days, 
consistent with the controlled substance import/export permits. If 
release by a customs officer will occur more than 180 calendar days 
after the declaration is deemed filed, the declarant must submit a new 
declaration for the transaction. The 180-calendar-day expiration 
provision for all controlled substance and listed chemical declarations 
is estimated to cause a small increase in the number of re-submissions 
of the declarations. The DEA estimates approximately 1% of all 
declarations would require re-submissions to replace the expiring 
declaration, requiring a total of an additional 85 controlled substance 
declarations and 132 listed chemical declarations per year. The 
estimated cost of each re-submission of controlled substance 
declarations and listed chemical declarations, based on estimated labor 
rates and time to complete the forms, is $13.02 and $7.81, 
respectively. There is no cost to tableting/encapsulating machine 
importers/exporters and brokers of international transactions, as this 
provision does not apply to these business activities. Based on the 
varying number of annual re-submissions estimated for each of the 
business activities, the DEA estimates this provision, if promulgated, 
would cost importers/exporters as a group $1,023, researchers as a 
group $24, analytical labs as a group $54, chemical importers/exporters 
as a group $689, and non-registered chemical importers/exporters as a 
group $344, for a total of $2,132. Based on the number of affected 
entities and the cost to the business activities as a group, the DEA 
estimated the average annual cost for each affected entity. The DEA 
estimates importers/exporters, researchers, analytical labs, chemical 
importers/exporters, and non-registered chemical importers/exporters 
will have an average cost impact of $3; $0; $0; $3; and $5 per year, 
respectively. (Figures are rounded.)
    In summary, the DEA combined the impact of the two provisions to 
estimate the net impact to the affected small entities. The DEA 
estimates an average annual net savings of $1,157 for the 310 
controlled substance importers/exporters, an average annual net savings 
of $1 for the 5,474 researchers, an average annual net savings of $31 
for the 1,134 analytical labs, an average annual net cost of $3 for the 
218 DEA-registered listed chemical importers/exporters, an average 
annual net cost of $5 for the 72 non-registered listed chemicals 
importers/exporters, an annual net cost of $71 for the 54 tableting/
encapsulating machine importers/exporters, no economic impact for the 
11 brokers of international transactions, no economic impact for the 44 
tableting/encapsulating machine domestic suppliers, and no economic 
impact for 4 entities selling EPH, PSE, PPA, and GHB by mail order.
    The DEA evaluated the net economic impact by size category for each 
of the business activities. The DEA estimates that the average annual 
cost savings of $1,157 for controlled substance importers/exporters is 
economically significant, cost savings greater than 1% of annual 
revenue, for 32 of 310 small importer/exporter entities. None of the 
remaining 7,011 small entities of the remaining business activities are 
estimated to be significantly impacted by this proposed rule. If the 
proposed rule were finalized, it would have a significant economic 
impact, in form of cost savings, on 32 (0.4%) of the 7,321 affected 
small entities. It is the DEA's assessment that 0.4% of small entities 
does not constitute a substantial number. The DEA's evaluation of 
economic impact by size category indicates that the proposed rule will 
not have a significant effect on a substantial number of these small 
entities.

Unfunded Mandates Reform Act of 1995

    The estimated annual impact of this rule is $429,650; thus, the DEA 
has determined in accordance with the Unfunded Mandates Reform Act of 
1995 (UMRA), 2 U.S.C. 1501 et seq., that this action would not result 
in any federal mandate that may result in the expenditure by State, 
local, and tribal governments, in the aggregate, or by the private 
sector, of $100,000,000 or more (adjusted for inflation) in any one 
year. Therefore, neither a Small Government Agency Plan nor any other 
action is required under provisions of UMRA.

Paperwork Reduction Act of 1995

    Pursuant to section 3507(d) of the Paperwork Reduction Act of 1995 
(PRA) (44 U.S.C. 3501 et seq.), the DEA has identified the following 
collections of information related to this proposed rule and has 
submitted this collection request to the Office of Management and 
Budget (OMB) for review and approval. This proposed rule updates the 
DEA regulations for import and export of controlled substances, listed 
chemicals, and tableting and encapsulating machines,. The proposal also 
clarifies certain policies and reflects current procedures and 
technological advancements. It allows for the implementation of the 
President's Executive Order on streamlining the export/import process, 
requiring the government-wide utilization of the International Trade 
Data System (ITDS). The DEA is not authorized to impose a penalty on 
persons for violating information collection requirements which do not 
display a current OMB control number, if one is required. Copies of 
existing information collections approved by OMB may be obtained at 
https://www.reginfo.gov/public/do/PRAMain.

A. Collections of Information Associated With the Proposed Rule

    The DEA is proposing to revise existing information collections 
1117-0004, 1117-0009 and 1117-0013 by establishing mandatory filing of 
return information for imports and exports of controlled substances.

[[Page 63602]]

    Additionally, the DEA is also proposing to revise existing 
information collection 1117-0024 by establishing two new forms for the 
reporting of transactions with listed chemicals, tableting machines, 
and encapsulating machines. Specifically, the DEA is creating new DEA 
Form 452, ``Reports for Regulated Machines.'' The DEA Form 452 will be 
used by regulated persons to report both domestic regulated 
transactions as well as import and export regulated transactions of 
tableting and encapsulating machines. The DEA is also establishing 
mandatory filing of return information for the importing and exporting 
of tableting and encapsulating machines that would be incorporated into 
the DEA Form 452. Additionally, the DEA is proposing to revise existing 
information collection 1117-0024 by establishing a new form for the 
reporting of unusual or excessive loss or disappearance of a listed 
chemical. Regulated persons would report this information on new DEA 
Form 107, ``Reports of Loss or Disappearance of Listed Chemicals.''
    The DEA is proposing to revise existing information collection 
1117-0033 by establishing a new form for reporting mail-order 
transactions involving specified listed chemicals. Specifically, the 
DEA is creating new DEA Form 453, ``Report of Mail Order 
Transactions.'' The DEA Form 453 will be used by regulated persons 
required to file monthly reports of transactions with nonregulated 
persons with ephedrine, pseudoephedrine, phenylpropanolamine, or gamma-
hydroxybutyric acid (including drug products containing these chemicals 
or controlled substance) and use or attempt to use the U.S. Postal 
Service or any private or commercial carrier as well as regulated 
persons required to file monthly reports of export transactions with 
ephedrine, pseudoephedrine, phenylpropanolamine, or gamma-
hydroxybutyric acid (including drug products containing these chemicals 
or controlled substance) and use or attempt to use the U.S. Postal 
Service or any private or commercial carrier.
1. Title: Application for Permit to Export Controlled Substances--DEA 
Form 161/Application for Permit to Export Controlled Substances for 
Subsequent Reexport--DEA Form 161R/Application for Permit to Export 
Controlled Substances for Subsequent Reexport Among Members of the 
European Economic Area--DEA Form 161R-EEA
    OMB Control Number: 1117-0004.
    Form Number: DEA Form 161, 161R, 161R-EEA.
    As part of the implementation of the ITDS, the DEA is proposing 
mandatory electronic filing of return information for any person who 
desires to export or reexport controlled substances listed in schedule 
I or II, any narcotic substance listed in schedules III or IV, or any 
non-narcotic substance in schedule II which the Administrator has 
specifically designated by regulation in Sec.  1312.30, or any non-
narcotic substance in schedule IV or V which is also listed in schedule 
I or II of the Convention on Psychotropic Substances, 1971.
    The DEA is proposing amendments to Sec.  1312.22 in the ITDS 
proposed rule to provide clear instructions on the process of return 
information for controlled substances subject to export permit 
requirements, which will be submitted electronically as part of the DEA 
Form 161. Specifically, the DEA is proposing to require in Sec.  
1312.22 that within 30 calendar days after a controlled substance is 
released by a customs officer at the port of export from the United 
States in accordance with the permitting process, or within 10 calendar 
days after receipt of a written request by the Administration to the 
exporter, whichever is sooner, the exporter must file a report with the 
Administration through the DEA Office of Diversion Control secure 
network application (available on the DEA Office of Diversion Control 
Web site) that such export has occurred and the specifics of the 
transaction.
    As part of the implementation of ITDS, the DEA is proposing to 
establish a new DEA Form 161R-EEA, discussed in greater detail below, 
to be used by registrants who export controlled substances for reexport 
among members of the European Economic Area. The existing DEA Form 161R 
would remain in use for exports of controlled substances that will be 
reexported to countries that are not members of the European Economic 
Area. The DEA is proposing amendments to Sec.  1312.22 in the ITDS 
proposed rule to provide clear instructions on the process of return 
information for controlled substances subject to reexport permit 
requirements that will be reexported outside of the European Economic 
Area, which will be submitted electronically as part of the DEA Form 
161R. Consistent with current requirements, the amended Sec.  1312.22 
would require that within 30 calendar days after a controlled substance 
is released by a customs officer at the port of export the exporter 
must file a report with the Administration through the DEA Office of 
Diversion Control secure network application (available on the DEA 
Office of Diversion Control Web site) that such export has occurred and 
the specifics of the transaction. Also consistent with current 
requirements, the amended text would require that the exporter must 
additionally electronically file a similar report of return information 
within 30 calendar days of the controlled substances being exported 
from the first country to the second country. As noted, the DEA Form 
161R, and associated return information, would be required to be 
accessed, completed, and submitted to the DEA through the DEA Office of 
Diversion Control secure network application.
    This proposal contains amendments that would implement section 4, 
Re-exportation Among Members of the European Economic Area, of the 
Improving Regulatory Transparency for New Medical Therapies Act, Public 
Law 114-89, which was signed into law on November 25, 2015. Section 4 
amended section 1003 of the Controlled Substances Import and Export Act 
(21 U.S.C. 953) by making changes to paragraph (f) and adding paragraph 
(g) that allows for reexportation of controlled substances among 
members of the European Economic Area. While other reexports must be 
completed no later than 180 days after initial export from the United 
States, controlled substances may continue to be reexported among 
members of the European Economic Area indefinitely, so long as the 
statutory conditions are met. As part of the implementation, the DEA is 
proposing to establish a new DEA Form 161R-EEA, ``Application for 
Permit to Export Controlled Substances for Subsequent Reexport Among 
Members of the European Economic Area,'' to be used by registrants who 
export controlled substances for reexport among members of the European 
Economic Area. Specifically, the DEA is proposing to require in Sec.  
1312.22 that within 30 calendar days after the controlled substance is 
released by a customs offer at the port of export the exporter must 
file a report with the Administration through the DEA Office of 
Diversion Control secure network application of the particulars of the 
transaction. The exporter must additionally file similar return 
information within 30 days of the controlled substances being exported 
from the first country to the second country and for each subsequent 
reexport among members of the European Economic Area. The DEA 
considered but ultimately did not choose to propose that such 
applications would be made electronically on the DEA Form 161R based on 
the fact that there are different

[[Page 63603]]

application requirements for the two types of transactions required by 
the CSA. Most important of these distinctions for tracking purposes are 
that reexports among members of the European Economic Area do not have 
a time period for which such transactions will ``close'' (i.e., all 
return information submitted). While under current Sec.  1312.22(d)(7) 
(proposed Sec.  1312.22(h)(6)), other reexports must be completed no 
later than 180 days after release by a customs officer at the port of 
export from the United States, the 2015 Act specifies that controlled 
substances may continue to be reexported among members of the European 
Economic Area indefinitely, so long as the statutory conditions are 
met. As noted, the DEA Form 161R-EEA, and associated return 
information, would be required to be accessed, completed, and submitted 
to the DEA through the DEA Office of Diversion Control secure network 
application.
    The DEA estimates that there will be 125 respondents to this 
information collection. The DEA estimates that the frequency of 
response will vary as DEA Form 161 is required to be completed by each 
respondent per each occurrence. The DEA estimates there will be a total 
of 5,386 responses. The DEA estimates, based on data from an already 
approved collection containing return information, that it will take 5 
minutes (online) to provide return information electronically and that 
the total annual burden will be 449 hours. The DEA estimates that the 
frequency of response will vary as DEA Form 161R and DEA Form 161R-EEA 
are required to be completed by each respondent per each occurrence. 
The DEA estimates there will be a combined total of 789 responses for 
DEA Form 161R and DEA Form 161R-EEA. Since the distinction between DEA 
Form 161R and DEA Form 161R-EEA does not currently exist, the DEA does 
not have an estimated number of responses for the two forms separately. 
Actual responses will be used for future information collection 
requests. Since return information is currently required for 
reexportations, the proposed rule does not create a new information 
collection burden for reexportations.
2. Title: Controlled Substances Import/Export Declaration--DEA Form 236
    OMB Control Number: 1117-0009.
    Form Number: DEA Form 236.
    As part of the implementation of the ITDS, the DEA is proposing 
mandatory electronic filing of return information for any person who 
desires to import non-narcotic substances in schedules III, IV, and V 
or to export non-narcotic substances in schedules III and IV and any 
other substance in schedule V.
    The DEA is proposing amendments to Sec.  1312.18(e) in the proposed 
rule to provide clear instructions on the process of return information 
for controlled substances imported under declaration procedures, which 
will be submitted electronically as part of the DEA Form 236 (Import 
declaration). The amended regulation would state that within 30 
calendar days after actual receipt of a controlled substance at the 
importer's registered location, or within 10 calendar days after the 
receipt of a written request by the Administration to the importer, 
whichever is sooner, the importer must report to the Administration 
utilizing the secure network application available on the DEA Office of 
Diversion Control Web site certifying that such import occurred and the 
details of the transaction.
    The DEA is proposing to amend Sec.  1312.27(d) in the proposed rule 
to provide clear instructions on the process of return information for 
controlled substances exported and reexported under declaration 
procedures, which will be submitted electronically as part of the DEA 
Form 236 (Export declaration). The amended regulation would state that 
within 30 calendar days after the controlled substance is released by a 
customs officer at the port of export or within 10 calendar days after 
receipt of a written request by the Administration to the exporter, 
whichever is sooner, the exporter must report to the Administration 
through the DEA Office of Diversion Control secure network application 
(available on the DEA Office of Diversion Control Web site) certifying 
that such export has occurred and the details of the transaction. For 
reexports under declaration procedures, the amended regulation states 
that within 30 calendar days after the controlled substance is exported 
from the first country to the second country, or within 10 calendar 
days after the receipt of a written request by the Administration to 
the exporter, whichever is sooner, the exporter must report to the 
Administration through the DEA Office of Diversion Control secure 
network application (available on the DEA Office of Diversion Control 
Web site) certifying that such export from the first country has 
occurred and the details of the transaction.
    The DEA estimates that there will be 341 respondents to this 
information collection. The DEA estimates that the frequency of 
response will vary as DEA Form 236 is required to be completed by each 
respondent per each occurrence. The DEA estimates there will be a total 
of 6,026 responses. The DEA estimates, based on data from an already 
approved collection containing return information, that it will take 5 
minutes (online) to provide return information electronically and that 
the total annual burden will be 502 hours.
3. Title: Application for Permit To Import Controlled Substances for 
Domestic and/or Scientific Purposes Pursuant to 21 U.S.C. 952
    OMB Control Number: 1117-0013.
    Form Number: DEA Form 357.
    As part of the implementation of the ITDS, the DEA is proposing 
mandatory electronic filing of return information for any person who 
desires to import any controlled substance listed in schedule I or II 
or any narcotic controlled substance listed in schedule III, IV, or V 
or any non-narcotic controlled substance in schedule III which the 
Administrator has specifically designed by regulation in 21 CFR 1312.30 
or any non-narcotic controlled substance in schedule IV or V which is 
also listed in schedule I or II of the Convention on Psychotropic 
Substances.
    The DEA is proposing amendments to current Sec.  1312.12(c) in the 
proposed rule to provide clear instructions on the process of return 
information for controlled substances imported under permit procedures, 
which will be submitted electronically as part of the DEA Form 357. 
Specifically, the DEA is proposing to require in proposed Sec.  
1312.12(d) that within 30 calendar days of actual receipt of a 
controlled substance at the importer's registered location, or within 
10 calendar days after receipt of a written request by the 
Administration, whichever is sooner, the importer must report to the 
Administration through the DEA Office of Diversion Control secure 
network application (available on the DEA Office of Diversion Control 
Web site) that such import occurred and the details of the transaction.
    The DEA estimates that there will be 148 respondents to this 
information collection. The DEA estimates that the frequency of 
response will vary as DEA Form 357 is required to be completed by each 
respondent per each occurrence. The DEA estimates there will be a total 
of 1,024 responses. The DEA estimates, based on data from an already 
approved collection containing return information, that it will take 5 
minutes (online) to provide return information electronically and that 
the total annual burden will be 85 hours.

[[Page 63604]]

4. Title: Reports of Loss or Disappearance of Listed Chemicals--DEA 
Form 107, and Regulated Transactions in Tableting/Encapsulating 
Machines--DEA Form 452
    OMB Control Number: 1117-0024.
    Form Number: DEA Form 107 and DEA Form 452.
    As part of the implementation of the ITDS, the DEA is proposing to 
establish a new DEA Form 452 to be used by regulated persons involved 
in regulated transactions in tableting or encapsulating machines. The 
DEA would standardize the current report required in the current Sec.  
1310.05(a)(4) for domestic regulated transactions in a tableting or 
encapsulating machine as well as the report required in the current 
Sec.  1310.05(c) for import and export of tableting and encapsulating 
machines. DEA Form 452 would be required to be accessed, completed, and 
submitted to the DEA through the DEA Office of Diversion Control secure 
network application.
    Moreover, under both the current and revised regulation, each 
regulated person must orally report any domestic regulated transaction 
in a tableting machine or an encapsulating machine to the Special Agent 
in Charge of the DEA Divisional Office for the area in which the 
regulated person making the report is located, although the DEA now 
proposes to clarify that the report must be made when the order is 
placed with the seller. The regulated person must subsequently file a 
written report of the domestic regulated transaction (on DEA Form 452) 
with the Administration through the DEA Office of Diversion Control 
secure network application within 15 calendar days after the order has 
been shipped by the seller. A report (on DEA Form 452) may contain 
multiple line entries for more than one transaction.
    Additionally, the DEA is proposing mandatory filing of return 
information for the import and export of tableting and encapsulating 
machines which will be electronically submitted as part of the DEA Form 
452. The amended regulation states that within 30 calendar days of the 
the shipment being released by a customs officer at the port of entry 
or port of export, or within 10 calendar days after the receipt of a 
written request by the Administration to the importer/exporter, 
whichever is sooner, the importer/exporter must report to the 
Administration through the DEA Office of Diversion Control secure 
network application (available on the DEA Office of Diversion Control 
Web site) certifying that such import/export occurred and the details 
of the transaction. Previously, Sec.  1310.05(c) instructed that 
regulated persons needed to provide notification of the import or 
export of a tableting machine or encapsulating machine on or before the 
date of exportation. However, the DEA has amended Sec.  1310.05(c) in 
order for DEA Form 452 to be submitted to the DEA at least 15 calendar 
days before the date of release by a customs officer at the port of 
entry or port of export in order to allow time for the DEA to review 
the information and transmit it into the ITDS prior to the actual 
import or export. 21 CFR 1310.05(c).
    As part of the implementation of the ITDS, the DEA is proposing to 
establish a new DEA Form 107 to be used by regulated persons involved 
in reporting unusual or excessive loss or disappearance of a listed 
chemical. The DEA would standardize the current report required to be 
filed in the current Sec.  1310.05(a)(3). Each regulated person must 
report to the Special Agent in Charge of the DEA Divisional Office for 
the area in which the regulated person making the report is located any 
unusual or excessive loss or disappearance of a listed chemical under 
the control of the regulated person. The regulated person will orally 
report to the Special Agent in Charge of the DEA Divisional Office at 
the earliest practicable opportunity after the regulated person becomes 
aware of the circumstances involved. The regulated person must also 
file a complete and accurate DEA Form 107 with the Administration 
through the DEA Office of Diversion Control secure network application 
within 15 calendar days after becoming aware of the circumstances 
requiring the report. Unusual or excessive losses or disappearances 
must be reported whether or not the listed chemical is subsequently 
recovered or the responsible parties are identified and action taken 
against them. DEA Form 107 would be required to be accessed, completed, 
and submitted to the DEA through the DEA Office of Diversion Control 
secure network application. While the report would be electronic, the 
filing requirements are essentially unchanged. The DEA estimates that 
the reporting burden would continue to be 20 minutes for each report.
    Specifically, based on publicly available information and 
historical data, the DEA estimates that there will be 130 respondents 
to this information collection, 60 for domestic transactions and 70 for 
imports or exports. The DEA estimates that the frequency of response 
will vary as DEA Form 452 is required to be completed by each 
respondent per each occurrence. As the DEA does not have a strong basis 
to estimate the number of responses for domestic transactions, the DEA 
makes an initial estimate (to be refined later) of 52 responses per 
week for each of 60 respondents, or a total of 3,120 domestic 
transaction related responses. Based on historical data, the DEA 
estimates there will be 917 import or export related responses for a 
grand total of 4,037 responses for domestic transactions, imports, and 
exports. Because of the information required on the DEA Form 452, the 
DEA estimates that this form will take 20 minutes to complete, 
including the oral report for domestic transactions and return 
information for imports and exports, and that the total annual burden 
will be 1,346 hours.
5. Title: Report of Mail Order Transactions--DEA Form 453
    OMB Control Number: 1117-0033.
    Form Number: DEA Form 453.
    As part of the implementation of the ITDS, the DEA is proposing to 
establish a new DEA Form 453, ``Report of Mail Order Transactions,'' to 
be used by regulated persons required to file monthly reports of 
transactions with nonregulated persons with ephedrine, pseudoephedrine, 
phenylpropanolamine, or gamma-hydroxybutyric acid (including drug 
products containing these chemicals or controlled substance) and use or 
attempt to use the U.S. Postal Service or a private or commercial 
carrier as well as regulated persons required to file monthly reports 
of export transactions with ephedrine, pseudoephedrine, 
phenylpropanolamine, or gamma-hydroxybutyric acid (including drug 
products containing these chemicals or controlled substance) and use or 
attempt to use the U.S. Postal Service or a private or commercial 
carrier. The DEA would require reports under the current Sec. Sec.  
1310.03(c) and 1310.06(i) to be submitted on a new DEA Form 453 which 
would be required to be accessed and submitted to the DEA through the 
DEA Office of Diversion Control secure network application.
    Additionally, the form would require the following information: The 
mail order transaction supplier name and registration number; the 
purchaser's name and address; the name and address shipped to (if 
different from purchaser's name and address); the name of the chemical 
contained in the scheduled listed chemical product and total quantity 
shipped (e.g., pseudoephedrine, 3 grams); the date of shipment; the 
product name; the dosage form (e.g., tablet, liquid, powder); the 
dosage strength; the number of dosage unites; the package type; the 
number of

[[Page 63605]]

packages; and the lot number. Previously, Sec.  1310.05(e) instructed 
that regulated persons submit a written report, containing the 
information listed above, on or before the 15th day of each month 
following the month in which the distributions took place. However, the 
DEA proposes to amend part 1310 in order for DEA Form 453 to be 
submitted to the DEA electronically on or before the 15th day of each 
month following the month in which the distributions took place.
    Specifically, based on historical data, the DEA estimates that 
there will be 7 respondents to this information collection. The 
respondents will provide 12 responses per year. The DEA estimates there 
will be a total of 84 responses per year. The DEA estimates that this 
form will take 15 minutes to complete and that the total annual burden 
will be 21 hours.

B. Request for Comments Regarding the Proposed Information Collections

    Under the PRA, the DEA is required to provide a notice regarding 
the proposed collections of information in the Federal Register with 
the notice of proposed rulemaking and solicit public comment. Section 
3506(c)(2)(A) and (B) of the PRA (44 U.S.C. 3506(c)(2)(A) and (B)) 
requires that the DEA solicit comment on the following issues:
    [ssquf] The need for the information collection and its usefulness 
in carrying out the proper functions of the DEA.
    [ssquf] The accuracy of the DEA's estimate of the burden of the 
proposed collection of information, including the validity of the 
methodology and assumptions used.
    [ssquf] The quality, utility, and clarity of the information to be 
collected.
    [ssquf] Recommendations to minimize the information collection 
burden on the affected public, including automated collection 
techniques.
    Written comments and suggestions from the public and affected 
agencies concerning the proposed collections of information are 
encouraged. Please send written comments to the Office of Information 
and Regulatory Affairs, OMB, Attention: Desk Officer for DOJ, 
Washington, DC 20503. Please state that your comments refer to RIN 
1117-AB41/Docket No. DEA-403.
    All comments must be submitted to OMB on or before October 17, 
2016. The final rule will respond to any OMB or public comments on the 
information collection requirements contained in this proposal.

List of Subjects

21 CFR Part 1300

    Chemicals, Drug traffic control.

21 CFR Part 1301

    Administrative practice and procedure, Drug traffic control, 
Exports, Imports, Security measures.

21 CFR Part 1302

    Drug traffic control, Exports, Imports, Labeling, Packaging and 
containers.

21 CFR Part 1303

    Administrative practice and procedure, Drug traffic control.

21 CFR Part 1304

    Drug traffic control, Reporting and recordkeeping requirements.

21 CFR Part 1308

    Administrative practice and procedure, Drug traffic control, 
Exports, Imports, Reporting and recordkeeping requirements.

21 CFR Part 1309

    Administrative practice and procedure, Drug traffic control, 
Exports, Imports.

21 CFR Part 1310

    Drug traffic control, Exports, Imports, Reporting and recordkeeping 
requirements.

21 CFR Part 1312

    Administrative practice and procedure, Drug traffic control, 
Exports, Imports, Reporting and recordkeeping requirements.

21 CFR Part 1313

    Administrative practice and procedure, Drug traffic control, 
Exports, Imports, Reporting and recordkeeping requirements.

21 CFR Part 1314

    Drug traffic control, Reporting and recordkeeping requirements.

21 CFR Part 1315

    Administrative practice and procedure, Chemicals, Drug traffic 
control, Imports, Reporting and recordkeeping requirements.

21 CFR Part 1316

    Administrative practice and procedure, Authority delegations 
(Government agencies), Drug traffic control, Research, Seizures and 
forfeitures.

21 CFR Part 1321

    Administrative practice and procedure.

    For the reasons stated in the preamble, the DEA proposes to amend 
21 CFR parts 1300, 1301, 1302, 1303, 1304, 1308, 1309, 1310, 1312, 
1313, 1314, 1315, 1316, and 1321 as follows:

PART 1300--DEFINITIONS

0
1. The authority citation for part 1300 continues to read as follows:

    Authority:  21 U.S.C. 802, 821, 822, 829, 871(b), 951, 958(f).

0
2. In Sec.  1300.01(b):
0
a. Add definitions for ``Competent national authority'' and ``Customs 
officer'' in alphabetical order;
0
b. Revise the definitions of ``Export'' and ``Import'';
0
c. Remove the definition of ``Jurisdiction of the United States'';
0
d. Add definitions for ``Port of entry'', ``Port of export'', ``Return 
information'', ``Shipment'', ``Split shipment'', and ``United States'' 
in alphabetical order.
    The additions and revisions read as follows:


Sec.  1300.01   Definitions relating to controlled substances.

* * * * *
    Competent national authority, for purposes of importation and 
exportation of controlled substances and listed chemicals, means an 
entity lawfully entitled to authorize the import and export of 
controlled substances, and to regulate or enforce national controls 
over listed chemicals, and included as such in the directory of 
``Competent National Authorities Under the International Drug Control 
Treaties'' published by the United Nations Office on Drugs and Crime. 
For purposes of exports of narcotic drugs, the term also includes 
freely associated states authorized to receive such exports pursuant to 
48 U.S.C. 1972.
* * * * *
    Customs officer means either an Officer of the Customs as defined 
in 19 U.S.C. 1401(h), or any individual duly authorized to accept 
entries of merchandise, to collect duties, and to enforce the customs 
laws of any commonwealth, territory, or possession of the United 
States.
* * * * *
    Export means, with respect to any article, any taking out or 
removal of such article from the United States (whether or not such 
taking out or removal constitutes an exportation within the meaning of 
the customs laws, export control laws enforced by other agencies, or 
related laws of the United States).
* * * * *
    Import means, with respect to any article, any bringing in or 
introduction of such article into the customs territory of the United 
States from any place outside thereof (but within the United States), 
or into the United States from any place outside thereof (whether or

[[Page 63606]]

not such bringing in or introduction constitutes an importation within 
the meaning of the tariff laws of the United States).
* * * * *
    Port of entry means, unless distinguished as being a foreign port 
of entry, any place at which a customs officer is duly authorized to 
accept entries of merchandise, to collect duties, and to enforce the 
various provisions of the customs laws of the United States (whether or 
not such place is a port of entry as defined in title 19 of the United 
States Code or its associated implementing regulations). Examples of 
ports of entry include, but are not limited to, places designated as 
ports of entry or customs stations in title 19 of the Code of Federal 
Regulations or by the governing customs authority of that area. When 
shipments are transported under U.S. Customs and Border Protection 
immediate transportation procedures, the port of entry shall be the 
port of final destination.
    Port of export means, unless distinguished as being a foreign port 
of export, any place under the control of a customs officer where goods 
are loaded on an aircraft, vessel or other conveyance for export 
outside of the United States. For goods loaded aboard an aircraft or 
vessel in the United States, that stops at several ports before 
departing the United States, the port of export is the first port where 
the goods were actually loaded. For goods off-loaded from the original 
conveyance to another conveyance (even if the aircraft or vessel 
belongs to the same carrier) at any port subsequent to the port where 
the first on-loading occurred in the United States, the port where the 
goods were loaded onto the last conveyance before departing the United 
States is the port of export.
* * * * *
    Return information means supplemental information required to be 
reported to the Administration following an import or export 
transaction containing the particulars of the transaction and any other 
information as the Administration may specify.
* * * * *
    Shipment means a quantity of goods or merchandise imported or 
exported at one place, at one time, for delivery to one consignee, on a 
single conveyance, at one place, on one bill of lading, air waybill, or 
other commercial loading document.
    Split shipment means a single import or export that is divided onto 
two or more conveyances.
* * * * *
    United States, when used in a geographic sense, means all places 
and waters, continental or insular, subject to the jurisdiction of the 
United States, which, in addition to the customs territory of the 
United States, include but are not limited to the U.S. Virgin Islands, 
Guam, American Samoa, and the Northern Mariana Islands.
* * * * *
0
3. In Sec.  1300.02(b):
0
a. Remove the definition of ``Chemical import'';
0
b. Add definitions for ``Competent national authority'', ``Customs 
officer'', ``Export'', and ``Import'' in alphabetical order;
0
c. Remove the definition of ``Jurisdiction of the United States''; and
0
d. Add definitions for ``Port of entry'', ``Port of export'', ``Return 
information'', ``Shipment'', ``Split shipment'', and ``United States'' 
in alphabetical order.
    The additions and revisions read as follows:


Sec.  1300.02   Definitions relating to listed chemicals.

* * * * *
    Competent national authority, for purposes of importation and 
exportation of controlled substances and listed chemicals, means an 
entity lawfully entitled to authorize the import and export of 
controlled substances, and to regulate or enforce national controls 
over listed chemicals, and included as such in the directory of 
``Competent National Authorities Under the International Drug Control 
Treaties'' published by the United Nations Office on Drugs and Crime.
    Customs officer means either an Officer of the Customs as defined 
in 19 U.S.C. 1401(h), or any individual duly authorized to accept 
entries of merchandise, to collect duties, and to enforce the customs 
laws of any commonwealth, territory, or possession of the United 
States.
* * * * *
    Export means, with respect to any article, any taking out or 
removal of such article from the United States (whether or not such 
taking out or removal constitutes an exportation within the meaning of 
the customs laws, export control laws enforced by other agencies, or 
related laws of the United States).
* * * * *
    Import means, with respect to any article, any bringing in or 
introduction of such article into the customs territory of the United 
States from any place outside thereof (but within the United States), 
or into the United States from any place outside thereof (whether or 
not such bringing in or introduction constitutes an importation within 
the meaning of the tariff laws of the United States).
* * * * *
    Port of entry, unless distinguished as being a foreign port of 
entry, means any place at which a customs officer is duly authorized to 
accept entries of merchandise, to collect duties, and to enforce the 
various provisions of the customs laws of the United States (whether or 
not such place is a port of entry as defined in title 19 of the United 
States Code or its associated implementing regulations). Examples of 
ports of entry include, but are not limited to, places designated as 
ports of entry or customs stations in title 19 of the Code of Federal 
Regulations or by the governing customs authority of that area. When 
shipments are transported under U.S. Customs and Border Protection 
immediate transportation procedures, the port of entry shall be the 
port of final destination.
    Port of export means, unless distinguished as being a foreign port 
of export, any place under the control of a customs officer where goods 
are loaded on an aircraft, vessel or other conveyance for export 
outside of the United States. For goods loaded aboard an aircraft or 
vessel in the United States that stops at several ports before 
departing the United States, the port of export is the first port where 
the goods were loaded. For goods off-loaded from the original 
conveyance to another conveyance (even if the aircraft or vessel 
belongs to the same carrier) at any port subsequent to the port where 
the first on-loading occurred in the United States, the port where the 
goods were loaded onto the last conveyance before departing the United 
States is the port of export. For reporting purposes, in the case of an 
otherwise lawful export occurring by mail, the port of export is the 
place of mailing.
* * * * *
    Return information means supplemental information required to be 
reported to the Administration following an import or export 
transaction containing the particulars of the transaction and any other 
information as the Administration may specify.
* * * * *
    Shipment means a quantity of goods or merchandise imported or 
exported at one place, at one time, for delivery to one consignee, on a 
single conveyance, at one place, on one bill of lading, air waybill, or 
other commercial loading document.

[[Page 63607]]

    Split shipment means a single import or export that is divided onto 
two or more conveyances.
* * * * *
    United States, when used in a geographic sense, means all places 
and waters, continental or insular, subject to the jurisdiction of the 
United States, which, in addition to the customs territory of the 
United States, include but are not limited to the U.S. Virgin Islands, 
Guam, American Samoa, and the Northern Mariana Islands.
* * * * *

PART 1301--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, AND 
DISPENSERS OF CONTROLLED SUBSTANCES

0
4. The authority citation for part 1301 continues to read as follows:

    Authority: 21 U.S.C. 821, 822, 823, 824, 831, 871(b), 875, 877, 
886a, 951, 952, 953, 956, 957, 958, 965.

0
5. Revise Sec.  1301.12(b)(3) to read as follows:


Sec.  1301.12   Separate registrations for separate locations.

* * * * *
    (b) * * *
    (3) An office used by a practitioner (who is registered at another 
location in the same State in which he or she practices) where 
controlled substances are prescribed but neither administered nor 
otherwise dispensed as a regular part of the professional practice of 
the practitioner at such office, and where no supplies of controlled 
substances are maintained.
* * * * *
0
6. Revise Sec.  1301.24(a)(1) to read as follows:


Sec.  1301.24  Exemption of law enforcement officials.

    (a) * * *
    (1) Any officer or employee of the Administration, any customs 
officer, any officer or employee of the U.S. Food and Drug 
Administration, and any other Federal or Insular officer who is 
lawfully engaged in the enforcement of any Federal law relating to 
controlled substances, drugs, or customs, and is duly authorized to 
possess or to import or export controlled substances in the course of 
his/her official duties; and
* * * * *
0
7. Revise Sec.  1301.26(b) introductory text to read as follows:


Sec.  1301.26   Exemption from import or export requirements for 
personal medical use.

* * * * *
    (b) The individual makes a declaration to an appropriate customs 
officer stating:
* * * * *
0
8. Revise Sec.  1301.34(c)(2) to read as follows:


Sec.  1301.34  Application for importation of Schedule I and II 
substances.

* * * * *
    (c) * * *
    (2) Employment of security procedures to guard against in-transit 
losses.
* * * * *
0
9. Revise Sec.  1301.74(c) introductory text to read as follows:


Sec.  1301.74   Other security controls for non-practitioners; narcotic 
treatment programs and compounders for narcotic treatment programs.

* * * * *
    (c) The registrant must notify the Field Division Office of the 
Administration in his or her area, in writing, of any theft or 
significant loss of any controlled substances within one business day 
of discovery of the theft or loss. Unless the theft or loss occurs 
during an import or export transaction, the supplier is responsible for 
reporting all in-transit losses of controlled substances by their agent 
or the common or contract carrier selected pursuant to paragraph (e) of 
this section, within one business day of discovery of such theft or 
loss. In an import transaction, once a shipment has been released by 
the customs officer at the port of entry, the importer is responsible 
for reporting all in-transit losses of controlled substances by their 
agent or the common or contract carrier selected pursuant to paragraph 
(e) of this section, within one business day of discovery of such theft 
or loss. In an export transaction, the exporter is responsible for 
reporting all in-transit losses of controlled substances by their agent 
or the common or contract carrier selected pursuant to paragraph (e) of 
this section within one business day of discovery of such theft or 
loss, until the shipment has been released by the customs officer at 
the port of export. The registrant must also complete, and submit to 
the Field Division Office in his or her area, DEA Form 106 regarding 
the theft or loss. Thefts and significant losses must be reported 
whether or not the controlled substances are subsequently recovered or 
the responsible parties are identified and action taken against them. 
When determining whether a loss is significant, a registrant should 
consider, among others, the following factors:
* * * * *

PART 1302--LABELING AND PACKAGING REQUIREMENTS FOR CONTROLLED 
SUBSTANCES

0
10. The authority citation for part 1302 continues to read as follows:

    Authority: 21 U.S.C. 821, 825, 871(b), 958(e).

0
11. Revise Sec.  1302.07 to read as follows:


Sec.  1302.07   Labeling and packaging requirements for imported and 
exported substances.

    (a) The symbol requirements of Sec. Sec.  1302.03 through 1302.05 
apply to every commercial container containing, and to all labeling of, 
controlled substances imported into the customs territory of the United 
States from any place outside thereof (but within the United States), 
or imported into the United States from any place outside thereof. 
These sealing and labeling requirements are in addition to any sealing 
requirements required under applicable customs laws.
    (b) The symbol requirements of Sec. Sec.  1302.03 through 1302.05 
do not apply to any commercial containers containing, or any labeling 
of, a controlled substance intended for export.
    (c) The sealing requirements of Sec.  1302.06 apply to every 
bottle, multiple dose vial, or other commercial container of any 
controlled substance listed in schedule I or II, or any narcotic 
controlled substance listed in schedule III or IV imported into the 
customs territory of the United States from any place outside thereof 
(but within the United States), or imported into the United States from 
any place outside thereof. The sealing requirements of Sec.  1302.06 
apply to every bottle, multiple dose vial, or other commercial 
container of any controlled substance listed in schedule I or II, or 
any narcotic controlled substance listed in schedule III or IV, 
exported or intended for export from the United States.

PART 1303--QUOTAS

0
12. The authority citation for part 1303 continues to read as follows:

    Authority: 21 U.S.C. 821, 826, 871(b).


Sec.  1303.12  [Amended]

0
13. Amend Sec.  1303.12 as follows:
0
a. In paragraph (b) by removing ``Drug and Chemical Evaluation Section, 
Drug Enforcement Administration'' from the last sentence and adding in 
its place ``UN Reporting and Quota Section, Office of Diversion 
Control''; and
0
b. In paragraph (d) by removing ``Drug & Chemical Evaluation Section, 
Drug

[[Page 63608]]

Enforcement Administration'' from the second sentence and adding in its 
place ``UN Reporting and Quota Section, Office of Diversion Control''.


Sec.  1303.22   [Amended]

0
14. In the introductory text to 1303.22, remove ``Drug & Chemical 
Evaluation Section, Drug Enforcement Administration'' and add in its 
place ``UN Reporting and Quota Section, Office of Diversion Control''.

PART 1304--RECORDS AND REPORTS OF REGISTRANTS

0
15. The authority citation for part 1304 continues to read as follows:

    Authority: 21 U.S.C. 821, 827, 831, 871(b), 958 (e)-(g), and 
965, unless otherwise noted.

0
16. Revise Sec.  1304.02 to read as follows:


Sec.  1304.02  Definitions.

    Any term contained in this part shall have the definition set forth 
in section 102 of the Act (21 U.S.C. 802) or Sec.  1300.01, Sec.  
1300.03, Sec.  1300.04, or Sec.  1300.05 of this chapter.
0
17. Revise Sec.  1304.21(d) to read as follows:


Sec.  1304.21  General requirements for continuing records.

* * * * *
    (d) In recording dates of receipt, distribution, other transfers, 
or destruction, the date on which the controlled substances are 
actually received, distributed, otherwise transferred, or destroyed 
will be used as the date of receipt, distribution, transfer, or 
destruction (e.g., invoices or packing slips, or DEA Form 41). In 
maintaining records concerning imports and exports, the registrant must 
record the date on which the controlled substances are released by a 
customs officer at the port of entry or port of export.
* * * * *


Sec.  1304.31  [Amended]

0
18. In Sec.  1304.31(a), remove ``Drug and Chemical Evaluation Section, 
Drug Enforcement Administration'' from the second sentence and add in 
its place ``UN Reporting and Quota Section, Office of Diversion 
Control''.


Sec.  1304.32  [Amended]

0
19. In Sec.  1304.32(a), remove ``Drug and Chemical Evaluation Section, 
Drug Enforcement Administration'' from the second sentence and add in 
its place ``UN Reporting and Quota Section, Office of Diversion 
Control''.
0
20. Revise Sec.  1304.33(a) and (f)(1) to read as follows:


Sec.  1304.33  Reports to Automation of Reports and Consolidated Orders 
System (ARCOS).

    (a) Reports generally. All reports required by this section shall 
be filed with the Pharmaceutical Investigations Section, Office of 
Diversion Control, Drug Enforcement Administration on DEA Form 333, or 
on media which contains the data required by DEA Form 333 and which is 
acceptable to the Administration. See the Table of DEA Mailing 
Addresses in Sec.  1321.01 of this chapter for the current mailing 
address.
* * * * *
    (f) * * *
    (1) A registered institutional practitioner that repackages or 
relabels exclusively for distribution or that distributes exclusively 
to (for dispensing by) agents, employees, or affiliated institutional 
practitioners of the registrant may be exempted from filing reports 
under this section by applying to the Pharmaceutical Investigations 
Section, Office of Diversion Control, Drug Enforcement Administration. 
See the Table of DEA Mailing Addresses in Sec.  1321.01 of this chapter 
for the current mailing address.
* * * * *

PART 1308--SCHEDULES OF CONTROLLED SUBSTANCES

0
21. The authority citation for part 1308 is revised to read as follows:

    Authority: 21 U.S.C. 811, 812, 871(b), 956(b), unless otherwise 
noted.

0
22. Revise Sec.  1308.01 to read as follows:


Sec.  1308.01  Scope of part 1308.

    Schedules of controlled substances established by section 202 of 
the Act (21 U.S.C. 812) and nonnarcotic substances, chemical 
preparations, veterinary anabolic steroid implant products, 
prescription products, anabolic steroid products, and cannabis plant 
material and products made therefrom that contain tetrahydrocannabinols 
excluded pursuant to section 201 of the Act (21 U.S.C. 811), as they 
are changed, updated, and republished from time to time, are set forth 
in this part.


Sec.  1308.21  [Amended]

0
23. In Sec.  1308.21(a), remove ``Office of Diversion Control, Drug 
Enforcement Administration'' and add in its place ``Drug and Chemical 
Evaluation Section, Office of Diversion Control, Drug Enforcement 
Administration''.


Sec.  1308.23  [Amended]

0
24. In Sec.  1308.23(b), remove ``Office of Diversion Control, Drug 
Enforcement Administration'' and add in its place ``Drug and Chemical 
Evaluation Section, Office of Diversion Control, Drug Enforcement 
Administration''.


Sec.  1308.25  [Amended]

0
25. In Sec.  1308.25(a), remove ``Office of Diversion Control, Drug 
Enforcement Administration'' and add in its place ``Drug and Chemical 
Evaluation Section, Office of Diversion Control, Drug Enforcement 
Administration''.


Sec.  1308.31  [Amended]

0
26. In Sec.  1308.31(a), remove ``Office of Diversion Control, Drug 
Enforcement Administration'' and add in its place ``Drug and Chemical 
Evaluation Section, Office of Diversion Control, Drug Enforcement 
Administration''.


Sec.  1308.33  [Amended]

0
27. In Sec.  1308.33(b), remove ``Office of Diversion Control, Drug 
Enforcement Administration'' and add in its place ``Drug and Chemical 
Evaluation Section, Office of Diversion Control, Drug Enforcement 
Administration''.
0
28. Revise Sec.  1308.49 to read as follows:


Sec.  1308.49  Temporary scheduling.

    (a) Pursuant to 21 U.S.C. 811(h) and without regard to the 
requirements of 21 U.S.C. 811(b) relating to the scientific and medical 
evaluation of the Secretary of Health and Human Services, the Drug 
Enforcement Administration may place a substance into Schedule I on a 
temporary basis, if it determines that such action is necessary to 
avoid an imminent hazard to the public safety. An order issued under 
this section may not be effective before the expiration of 30 calendar 
days from:
    (1) The date of publication by the Administration of a notice in 
the Federal Register of its intention to issue such order and the 
grounds upon which such order is to be issued, and
    (2) The date the Administration has transmitted notification to the 
Secretary of Health and Human Services of the Administration's 
intention to issue such order.
    (b) An order issued under this section will be vacated upon the 
conclusion of a subsequent rulemaking proceeding initiated under 
section 201(a) (21 U.S.C. 811(a)) with respect to such substance or at 
the end of two years from the effective date of the order scheduling 
the substance, except that during the pendency of proceedings under 
section 201(a) (21 U.S.C. 811(a)) with respect to the substance, the 
Administration may extend the temporary scheduling for up to one year.

[[Page 63609]]

PART 1309--REGISTRATION OF MANUFACTURERS, DISTRIBUTORS, IMPORTERS 
AND EXPORTERS OF LIST I CHEMICALS

0
29. The authority citation for part 1309 continues to read as follows:

    Authority: 21 U.S.C. 802, 821, 822, 823, 824, 830, 871(b), 875, 
877, 886a, 952, 953, 957, 958.

0
30. Revise Sec.  1309.26(a)(1) to read as follows:


Sec.  1309.26  Exemption of law enforcement officials.

    (a) * * *
    (1) Any officer or employee of the Administration, any customs 
officer, any officer or employee of the U.S. Food and Drug 
Administration, and any Federal or Insular officer who is lawfully 
engaged in the enforcement of any federal law relating to listed 
chemicals, controlled substances, drugs, or customs, and is duly 
authorized to possess and distribute List I chemicals in the course of 
his/her official duties; and
* * * * *
0
31. Revise Sec.  1309.32(d) to read as follows:


Sec.  1309.32  Application forms; contents; signature.

* * * * *
    (d) Each application for registration must include the 
Administration Chemical Code Number, as set forth in Sec.  1310.02 of 
this chapter, for each List I chemical to be manufactured, distributed, 
imported, or exported.
* * * * *


Sec.  1309.46  [Amended]

0
32. In Sec.  1309.46(d), remove ``Sec.  1309.54'' and add in its place 
``Sec.  1309.53''.


Sec.  1309.51  [Amended]

0
33. In Sec.  1309.51(a), remove ``1309.57'' and add in its place 
``1309.55''.
0
34. Revise Sec.  1309.71(b)(5) and (7) to read as follows:


Sec.  1309.71  General security requirements.

* * * * *
    (b) * * *
    (5) The extent of unsupervised public access to the facility;
* * * * *
    (7) The procedures for handling business guests, visitors, 
maintenance personnel, and nonemployee service personnel in areas where 
List I chemicals are processed or stored; and
* * * * *

PART 1310--RECORDS AND REPORTS OF LISTED CHEMICALS AND CERTAIN 
MACHINES; IMPORTATION AND EXPORTATION OF CERTAIN MACHINES

0
35. The authority citation for part 1310 continues to read as follows:

    Authority: 21 U.S.C. 802, 827(h), 830, 871(b), 890.

0
36. Revise the heading of part 1310 to read as set forth above.
0
37. Amend Sec.  1310.03 as follows:
0
a. In paragraph (b) by removing ``Section 1310.05'' and adding in its 
place ``Sec.  1310.05''; and
0
b. Revising paragraph (c) to read as follows:


Sec.  1310.03  Persons required to keep records and file reports.

* * * * *
    (c) Each regulated person who engages in a transaction with a 
nonregulated person which involves ephedrine, pseudoephedrine, 
phenylpropanolamine, or gamma hydroxybutyric acid (including drug 
products containing these chemicals or controlled substance), and uses 
or attempts to use the U.S. Postal Service or any private or commercial 
carrier must, on a monthly basis, report to the Administration each 
such transaction conducted during the previous month as specified in 
Sec. Sec.  1310.05(e) and 1310.06(k) on DEA Form 453 through the DEA 
Office of Diversion Control secure network application. Each regulated 
person who engages in an export transaction which involves ephedrine, 
pseudoephedrine, phenylpropanolamine, or gamma hydroxybutyric acid 
(including drug products containing these chemicals or controlled 
substance), and uses or attempts to use the U.S. Postal Service or any 
private or commercial carrier must, on a monthly basis, report each 
such transaction conducted during the previous month as specified in 
Sec. Sec.  1310.05(e) and 1310.06(k) on DEA Form 453 through the DEA 
Office of Diversion Control secure network application.
* * * * *
0
38. Revise Sec.  1310.05(a) through (e) to read as follows:


Sec.  1310.05  Reports.

    (a)(1) Each regulated person must report to the Special Agent in 
Charge of the DEA Divisional Office for the area in which the regulated 
person making the report is located any regulated transaction involving 
an extraordinary quantity of a listed chemical, an uncommon method of 
payment or delivery, or any other circumstance that the regulated 
person believes may indicate that the listed chemical will be used in 
violation of this part. The regulated person will orally report to the 
Special Agent in Charge of the DEA Divisional Office at the earliest 
practicable opportunity after the regulated person becomes aware of the 
circumstances involved and as much in advance of the conclusion of the 
transaction as possible. The regulated person must file a written 
report of the transaction(s) with the Special Agent in Charge of the 
DEA Divisional Office as set forth in Sec.  1310.06 within 15 calendar 
days after the regulated person becomes aware of the circumstances of 
the event.
    (2) Each regulated person must report to the Special Agent in 
Charge of the DEA Divisional Office for the area in which the regulated 
person making the report is located any proposed regulated transaction 
with a person whose description or other identifying characteristic the 
Administration has previously furnished to the regulated person. The 
regulated person will orally report to the Special Agent in Charge of 
the DEA Divisional Office at the earliest practicable opportunity after 
the regulated person becomes aware of the circumstances involved. A 
transaction may not be completed with a person whose description or 
identifying characteristic has previously been furnished to the 
regulated person by the Administration unless the transaction is 
approved by the Administration.
    (b)(1) Each regulated person must report to the Special Agent in 
Charge of the DEA Divisional Office for the area in which the regulated 
person making the report is located any unusual or excessive loss or 
disappearance of a listed chemical under the control of the regulated 
person. The regulated person will orally report to the Special Agent in 
Charge of the DEA Divisional Office at the earliest practicable 
opportunity after the regulated person becomes aware of the 
circumstances involved. Unless the loss or disappearance occurs during 
an import or export transaction, the supplier is responsible for 
reporting all in-transit losses of any listed chemical by their agent 
or the common or contract carrier. In an import transaction, once a 
shipment has been released by the customs officer at the port of entry, 
the importer is responsible for reporting all in-transit losses of any 
listed chemical by their agent or the common or contract carrier. In an 
export transaction, the exporter is responsible for reporting all in-
transit losses of any listed chemical by their agent or the common or 
contract carrier until the shipment has been released by the customs 
officer at the port of export.

[[Page 63610]]

The regulated person must also file a complete and accurate DEA Form 
107, in accordance with Sec.  1310.06(d), with the Administration 
through the DEA Office of Diversion Control secure network application 
within 15 calendar days after becoming aware of the circumstances 
requiring the report. Unusual or excessive losses or disappearances 
must be reported whether or not the listed chemical is subsequently 
recovered or the responsible parties are identified and action taken 
against them. When determining whether a loss or disappearance of a 
listed chemical was unusual or excessive, the regulated persons should 
consider, among others, the following factors:
    (i) The actual quantity of a listed chemical;
    (ii) The specific listed chemical involved;
    (iii) Whether the loss or disappearance of the listed chemical can 
be associated with access to those listed chemicals by specific 
individuals, or whether the loss or disappearance can be attributed to 
unique activities that may take place involving the listed chemical;
    (iv) A pattern of losses or disappearances over a specific time 
period, whether the losses or disappearances appear to be random, and 
the result of efforts taken to resolve the losses.
    (v) If known, the regulated person should also consider whether the 
specific listed chemical was a likely candidate for diversion as well 
as local trends and other indicators of the diversion potential of the 
listed chemical.
    (2) Each regulated person must orally report any domestic regulated 
transaction in a tableting machine or an encapsulating machine to the 
Special Agent in Charge of the DEA Divisional Office for the area in 
which the regulated person making the report is located when the order 
is placed with the seller. The regulated person also must file a report 
of the transaction (on DEA Form 452) with the Administration through 
the DEA Office of Diversion Control secure network application within 
15 calendar days after the order has been shipped by the seller. A 
report (DEA Form 452) may list more than one machine for a single 
transaction. Upon receipt and review, the Administration will assign a 
completed report a transaction identification number. The report will 
not be deemed filed until a transaction identification number has been 
issued by the Administration.
    (c) Imports and exports of tableting machines and encapsulating 
machines. (1) Each regulated person who imports or exports a tableting 
machine, or encapsulating machine, must file a report of such 
importation or exportation on DEA Form 452 with the Administration 
through the DEA Office of Diversion Control secure network application, 
at least 15 calendar days before the anticipated arrival at the port of 
entry or port of export. In order to facilitate the importation or 
exportation of any tableting machine or encapsulating machine and 
implement the purpose of the Act, regulated persons may report to the 
Administration as far in advance as possible. A separate report (DEA 
Form 452) must be filed for each shipment, in accordance with Sec.  
1310.06(e). Upon receipt and review, the Administration will assign a 
completed report a transaction identification number. The report will 
not be deemed filed until a transaction identification number has been 
issued by the Administration. The importer or exporter may only proceed 
with the transaction once the transaction identification number has 
been issued. Any tableting machine or encapsulating machine may be 
imported or exported if that machine is needed for medical, commercial, 
scientific, or other legitimate uses. However, an importation or 
exportation of a tableting machine or encapsulating machine may not be 
completed with a person whose description or identifying characteristic 
has previously been furnished to the regulated person by the 
Administration unless the transaction is approved by the 
Administration.
    (2) Denied release at the port of entry. In the event that a 
shipment of tableting or encapsulating machine(s) has been denied 
release by a customs officer at the port of entry for any reason, the 
importer who attempted to import the shipment must, within 24 hours of 
the denial, report to the Administration that the shipment was denied, 
the basis for denial, and such other information as is required by 
Sec.  1310.06(g). Such report must be transmitted to the Administration 
through the DEA Office of Diversion Control secure network application. 
Upon the importer's report of a denied entry, DEA will assign the 
report a transaction identification number and the original import 
notification will be void and of no effect. No shipment of tableting 
machines or encapsulating machines denied entry for any reason will be 
allowed entry without a subsequent refiling of an amended DEA Form 452 
by the regulated person. In such circumstances, the regulated person 
may proceed with the release of the tableting machines or encapsulating 
machines upon receipt of a transaction identification number for the 
refiled and amended DEA Form 452 without regard to the 15-day advance 
filing requirement in paragraph (c)(1) of this section, so long as the 
article is otherwise cleared for entry under U.S. customs laws.
    (d) Each regulated bulk manufacturer of a listed chemical must 
submit manufacturing, inventory and use data on an annual basis as set 
forth in Sec.  1310.06(j). This data must be submitted annually to the 
Drug and Chemical Evaluation Section, Office of Diversion Control, Drug 
Enforcement Administration, on or before the 15th day of March of the 
year immediately following the calendar year for which submitted. See 
the Table of DEA Mailing Addresses in Sec.  1321.01 of this chapter for 
the current mailing address. A business entity which manufactures a 
listed chemical may elect to report separately by individual location 
or report as an aggregate amount for the entire business entity 
provided that they inform the DEA of which method they will use. This 
reporting requirement does not apply to drugs or other products that 
are exempted under paragraph (1)(iv) or (v) of the definition of 
regulated transaction in Sec.  1300.02 of this chapter except as set 
forth in Sec.  1310.06(i)(5). Bulk manufacturers that produce a listed 
chemical solely for internal consumption are not required to report for 
that listed chemical. For purposes of these reporting requirements, 
internal consumption consists of any quantity of a listed chemical 
otherwise not available for further resale or distribution. Internal 
consumption includes (but is not limited to) quantities used for 
quality control testing, quantities consumed in-house, or production 
losses. Internal consumption does not include the quantities of a 
listed chemical consumed in the production of exempted products. If an 
existing standard industry report contains the information required in 
Sec.  1310.06(j) and such information is separate or readily 
retrievable from the report, that report may be submitted in 
satisfaction of this requirement. Each report must be submitted to the 
DEA under company letterhead and signed by an appropriate, responsible 
official. For purposes of this paragraph only, the term regulated bulk 
manufacturer of a listed chemical means a person who manufactures a 
listed chemical by means of chemical synthesis or by extraction from 
other substances. The term bulk manufacturer does not include persons 
whose sole activity consists of the repackaging or

[[Page 63611]]

relabeling of listed chemical products or the manufacture of drug 
dosage forms of products which contain a listed chemical.
    (e) Each regulated person required to report pursuant to Sec.  
1310.03(c) must file a report containing the transaction identification 
number for each such transaction (if the regulated person is required 
to obtain a transaction identification number under part 1313 of this 
chapter) and information set forth in Sec.  1310.06(k), on or before 
the 15th day of each month following the month in which the 
distributions took place.
* * * * *
0
39. Revise Sec.  1310.06 to read as follows:


Sec.  1310.06  Content of records and reports.

    (a) Each record required by Sec.  1310.03(a) must include the 
following:
    (1) The name/business name, address/business address, and contact 
information (e.g., telephone number(s), email address(es), etc.), and, 
if required, DEA registration number of each party to the regulated 
transaction.
    (2) The date of the regulated transaction.
    (3) The quantity, chemical name, and, if applicable, National Drug 
Code (NDC) number. If NDC number is not applicable, the form of 
packaging of the listed chemical or a description of the tableting 
machine or encapsulating machine (including make, model serial number, 
if any, and whether the machine is manual or electric).
    (4) The method of transfer (company truck, picked up by customer, 
etc.).
    (5) The type of identification used by the purchaser and any unique 
number on that identification.
    (b) For purposes of this section, normal business records will be 
considered adequate if they contain the information listed in paragraph 
(a) of this section and are readily retrievable from other business 
records of the regulated person. For prescription drug products, 
prescription and hospital records kept in the normal course of medical 
treatment will be considered adequate for satisfying the requirements 
of paragraph (a) of this section with respect to dispensing to 
patients, and records required to be maintained pursuant to the U.S. 
Food and Drug Administration regulations relating to the distribution 
of prescription drugs, as set forth in 21 CFR part 205, will be 
considered adequate for satisfying the requirements of paragraph (a) of 
this section with respect to distributions.
    (c)(1) Each report required by Sec.  1310.05(a) must include the 
information as specified by Sec.  1310.06(a), the basis for making the 
report, and, where obtainable, the registration number of the other 
party, if such party is registered. A report of an uncommon method of 
payment or delivery submitted in accordance with Sec.  1310.05(a)(1) 
must also include a reason why the method of payment or delivery was 
uncommon.
    (2) A suggested format for the reports in Sec.  1310.05(a)(1) is 
provided below:

    Supplier:
Registration Number (if registered)------------------------------------
Name-------------------------------------------------------------------
Address----------------------------------------------------------------
City-------------------------------------------------------------------
State------------------------------------------------------------------
Zip--------------------------------------------------------------------
Contact Information:---------------------------------------------------

    Purchaser:
Registration Number (if registered)------------------------------------
Name-------------------------------------------------------------------
Address----------------------------------------------------------------
City-------------------------------------------------------------------
State------------------------------------------------------------------
Zip--------------------------------------------------------------------
Contact Information----------------------------------------------------
Identification---------------------------------------------------------

    Shipping Address (if different than purchaser Address):
Street-----------------------------------------------------------------
City-------------------------------------------------------------------
State------------------------------------------------------------------
Zip--------------------------------------------------------------------
Date of Shipment-------------------------------------------------------

    Description of Listed Chemical:
Chemical Name----------------------------------------------------------
Quantity---------------------------------------------------------------
National Drug Code (NDC) Number(s), or Form(s) of Packaging------------

    Other:
The basis (i.e., reason) for making the report:------------------------
Any additional pertinent
information:-----------------------------------------------------------
    (d) Each report of an unusual or excessive loss or disappearance of 
a listed chemical required by Sec.  1310.05(b)(1) (on DEA Form 107), 
must include the following information:
    (1) The name/business name, address/business address, and contact 
information (e.g., telephone number(s), email address(es), etc.), and, 
if applicable, DEA registration number of each party to the regulated 
transaction.
    (2) The date (or estimated date) on which unusual or excessive loss 
or disappearance occurred, and the actual date on which the unusual or 
excessive loss or disappearance was discovered by the regulated person.
    (3) The quantity, chemical name, and National Drug Code (NDC) 
number, if applicable or if not the form of packaging of the listed 
chemical.
    (4) The type of business conducted by the regulated person, (e.g., 
grocery store, pharmacy/drug store, discount department store, 
warehouse club or superstore, convenience store, specialty food store, 
gas station, mobile retail vendor, mail-order, etc.) if the regulated 
person is not a DEA registrant.
    (e)(1) Each report of an importation of a tableting machine or an 
encapsulating machine required by Sec.  1310.05(c)(1) (on DEA Form 452) 
must include the following information:
    (i) The name/business name, address/business address, and contact 
information (e.g., telephone number(s), email address(es), etc.) of the 
regulated person; the name/business name, address/business address, and 
contact information (e.g., telephone number(s), email address(es), 
etc.) of the import broker or forwarding agent, if any;
    (ii) A description of each machine (including make, model, serial 
number, if any, and whether the machine is manual or electric) and the 
number of machines being received;
    (iii) The anticipated date of arrival at the port of entry, and the 
anticipated port of entry; and
    (iv) The name/business name, address/business address, and contact 
information (e.g., telephone number(s), email address(es), etc.) of the 
consignor in the foreign country of exportation.
    (v) The intended medical, commercial, scientific, or other 
legitimate use of the machine.
    (vi) Any proposed changes in identifying information of the 
imported machines (e.g., name, brand, serial number, if any, etc.) that 
will take place after importation.
    (2) Each report of an exportation of a tableting machine or an 
encapsulating machine required by Sec.  1310.05(c)(1) (on DEA Form 452) 
must include the following information:
    (i) The name/business name, address/business address, and contact 
information (e.g., telephone number(s), email address(es), etc.) of the 
regulated person; the name/business name, address/business address, and 
contact information (e.g., telephone number(s), email address(es), 
etc.) of the export broker (if applicable):
    (ii) A description of each machine (including make, model, serial 
number, if any, and whether the machine is manual or electric) and the 
number of machines being received;
    (iii) The anticipated date of arrival at the port of export, the 
foreign port and country of entry; and
    (iv) The name/business name, address/business address, and contact 
information (e.g., telephone number(s), email address(es), etc.) of the 
consignee in the country where the shipment is destined; the name(s)/
business name(s)

[[Page 63612]]

and address(es)/business address(es), and contact information (e.g., 
telephone number(s), email address(es), etc.) of the intermediate 
consignee(s) (if any).
    (f) Each report of a domestic regulated transaction in a tableting 
machine or encapsulating machine required by Sec.  1310.05(b)(2) (on 
DEA Form 452) must include the following information:
    (1) The name/business name, address/business address, and contact 
information (e.g., telephone number(s), email address(es), etc.) of the 
regulated person; the name/business name, address/business address, and 
contact information (e.g., telephone number(s), email address(es), 
etc.) of the purchaser;
    (2) A description of each machine (including make, model, serial 
number, if any, and whether the machine is manual or electric) and the 
number of machines being received;
    (3) Any changes made by the regulated person in identifying 
information of the machines (e.g., name, brand, serial number, etc.).
    (g) Each report of a denied release by a customs officer at the 
port of entry of a tableting machine or an encapsulating machine 
required by Sec.  1310.05(c)(2) must include the following information: 
The quantity of machines denied release; a concise description of the 
machines denied relese; the date on which release was denied; the port 
where the denial of release was issued from; and the basis for the 
denial.
    (h) Return information. (1) Within 30 calendar days after actual 
receipt of a tableting or encapsulating machine, or within 10 calendar 
days after receipt of a written request by the Administration to the 
importer, whichever is sooner, the importer must file a report with the 
Administration (on DEA Form 452) specifying the particulars of the 
transaction utilizing the DEA Office of Diversion Control secure 
network application. This report must include the following 
information: The date on which a customs officer at the port of entry 
released the machine(s)); the date on which the machine(s) arrived at 
the final destination; the port of entry where the machine(s) were 
actually released by a customs officer; the actual quantity of machines 
released by a customs officer; the actual quantity of machines that 
arrived at the final destination; a description of each tableting or 
encapsulating machine imported (including make, model, and serial 
number, if any); any changes in identifying information of the imported 
machines (e.g., name, brand, serial number, if any, etc.) that will 
take place after importation; and any other information as the 
Administration may from time to time specify. Upon receipt and review, 
the Administration will assign a transaction identification number to a 
completed report. The report will not be deemed filed until the 
Administration has issued a transaction identification number. A single 
return declaration may include the particulars of both the importation 
and distribution. For DEA reporting purposes, import responsibilities 
are concluded upon the receipt of the machines by the importer. Once 
machines are received by the importer, domestic transaction reporting 
requirements commence. Distributions of tableting and encapsulating 
machines from the importer to their customers must be reported as 
domestic regulated transactions in accordance with Sec.  1310.05(b)(2).
    (2) Within 30 calendar days after the tableting or encapsulating 
machine is released by a customs officer at the port of export, or 
within 10 calendar days after receipt of a written request by the 
Administration to the exporter, whichever is sooner, the exporter must 
file a report with the Administration (on DEA Form 452) through the DEA 
Office of Diversion Control secure network application specifying the 
particulars of the transaction. This report must include the following 
information: The date on which the the machine(s) was(were) released by 
a customs officer at the port of export; the actual quantity of 
machines released; a description of each tableting or encapsulating 
machine released (including make, model, serial number, if any, and 
whether the machine is manual or electric); and any other information 
as the Administration may from time to time specify.
    (i) Declared exports of machines which are refused, rejected, or 
otherwise deemed undeliverable may be returned to the U.S. exporter of 
record. A brief written report outlining the circumstances must be 
filed with the Administration through the DEA Office of Diversion 
Control secure network application, following the return at the 
earliest practicable opportunity after the regulated person becomes 
aware of the circumstances involved. This provision does not apply to 
shipments that have cleared foreign customs, been delivered, and 
accepted by the foreign consignee. Returns to third parties in the 
United States will be regarded as imports.
    (j) Each annual report required by Sec.  1310.05(d) must provide 
the following information for each listed chemical manufactured:
    (1) The name/business name, address/business address, and contact 
information (e.g., telephone number(s), email address(es), etc.) and 
chemical registration number (if any) of the manufacturer.
    (2) The aggregate quantity of each listed chemical that the company 
manufactured during the preceding calendar year.
    (3) The year-end inventory of each listed chemical as of the close 
of business on the 31st day of December of each year. (For each listed 
chemical, if the prior period's ending inventory has not previously 
been reported to DEA, this report should also detail the beginning 
inventory for the period.) For purposes of this requirement, inventory 
shall reflect the quantity of listed chemicals, whether in bulk or non-
exempt product form, held in storage for later distribution. Inventory 
does not include waste material for destruction, material stored as an 
in-process intermediate or other in-process material.
    (4) The aggregate quantity of each listed chemical used for 
internal consumption during the preceding calendar year, unless the 
chemical is produced solely for internal consumption.
    (5) The aggregate quantity of each listed chemical manufactured 
which becomes a component of a product exempted from paragraph (1)(iv) 
or (v) of the definition of regulated transaction in Sec.  1300.02 of 
this chapter during the preceding calendar year.
    (6) Data shall identify the specific isomer, salt or ester when 
applicable but quantitative data shall be reported as anhydrous base or 
acid in kilogram units of measure.
    (k) Each monthly report required by Sec. Sec.  1310.03(c) and 
1310.05(e) (on DEA Form 453) must provide the following information for 
each transaction:
    (1) Supplier name/business name, address/business address, and 
contact information (e.g., telephone number(s), email address(es), 
etc.) and registration number.
    (2) Purchaser's name/business name, address/business address, and 
contact information (e.g., telephone number(s), email address(es), 
etc.).
    (3) Name/business name, address/business address shipped to (if 
different from purchaser's name/address).
    (4) Chemical name, National Drug Code (NDC) number, if applicable, 
and total amount shipped.
    (5) Date of shipment.
    (6) Product name (if drug product).
    (7) Dosage form (if drug product) (e.g., pill, tablet, liquid).
    (8) Dosage strength (if drug product) (e.g., 30mg, 60mg, per dose 
etc.).
    (9) Number of dosage units (if drug product) (e.g., 100 doses per 
package).
    (10) Package type (if drug product) (e.g., bottle, blister pack, 
etc.).
    (11) Number of packages (if drug product) (e.g., 10 bottles).

[[Page 63613]]

    (12) Lot number (if drug product).
    (l) Information provided in reports required by Sec.  1310.05(e) 
which is exempt from disclosure under 5 U.S.C. 552(a), by reason of 5 
U.S.C. 552(b)(6), will be provided the same protections from disclosure 
as are provided in section 310(c) of the Act (21 U.S.C. 830(c)) for 
confidential business information.


Sec.  1310.13   [Amended]

0
40. In Sec.  1310.13(b), remove ``Office of Diversion Control, Drug 
Enforcement Administration'' and add in its place ``Drug and Chemical 
Evaluation Section, Office of Diversion Control, Drug Enforcement 
Administration''.

PART 1312--IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES

0
41. The authority citation for part 1312 continues to read as follows:

    Authority: 21 U.S.C. 952, 953, 954, 957, 958.
0
42. Add Sec.  1312.03 to precede the undesignated center heading 
Importation of Controlled Substances to read as follows:


Sec.  1312.03   Forms applicable to this part.

------------------------------------------------------------------------
                     Form                          Access/ submission
------------------------------------------------------------------------
DEA Form 35, Permit to Import................  electronic.
DEA Form 36, Permit to Export................  electronic.
DEA Form 161, Application for Permit to        electronic.
 Export Controlled Substances.
DEA Form 161R, Application for Permit to       electronic.
 Export Controlled Substances For Subsequent
 Reexport.
DEA Form 161R-EEA, Application for Permit to   electronic.
 Export Controlled Substances for Subsequent
 Reexport among members of the European
 Economic Area.
DEA Form 236, Controlled Substances Import/    electronic.
 Export Declaration.
DEA Form 357, Application for Permit to        electronic.
 Import Controlled Substances for Domestic
 And/Or Scientific Purposes.
------------------------------------------------------------------------

0
43. Revise Sec.  1312.11 to read as follows:


Sec.  1312.11   Requirement of authorization to import.

    (a) No person shall import, or cause to be imported, into the 
customs territory of the United States from any place outside thereof 
(but within the United States), or into the United States from any 
place outside thereof, any controlled substances listed in Schedule I 
or II, or any narcotic controlled substance listed in Schedule III, IV, 
or V, or any non-narcotic controlled substance listed in Schedule III 
which the Administrator has specifically designated by regulation in 
Sec.  1312.30 or any non-narcotic controlled substance listed in 
Schedule IV or V which is also listed in Schedule I or II of the 
Convention on Psychotropic Substances, 1971, unless and until such 
person is properly registered under the Act (or, in accordance with 
part 1301 of this chapter, exempt from registration) and the 
Administration has issued him or her a permit to do so in accordance 
with Sec.  1312.13.
    (b) No person shall import, or cause to be imported, into the 
customs territory of the United States from any place outside thereof 
(but within the United States), or into the United States from any 
place outside thereof, any non-narcotic controlled substance listed in 
Schedule III, IV, or V, excluding those described in paragraph (a) of 
this section, unless and until such person is properly registered under 
the Act (or, in accordance with part 1301 of this chapter, exempt from 
registration) and has filed an import declaration to do so in 
accordance with Sec.  1312.18.
    (c) A separate permit or declaration is required for each shipment 
of a controlled substance to be imported.
0
44. Revise Sec.  1312.12 to read as follows:


Sec.  1312.12  Application for import permit; return information.

    (a) Registered importers, other registrants authorized to import as 
a coincident activity of their registrations, and persons who in 
accordance with part 1301 of this chapter are exempt from registration, 
seeking to import a controlled substance in schedule I or II; any 
narcotic drug in schedule III, IV, or V; any non-narcotic drug in 
schedule III that has been specifically designated by regulation in 
Sec.  1312.30 of this part; or any non-narcotic substance listed in 
schedule IV or V that is also listed in schedule I or II of the 
Convention on Psychotropic Substances, 1971, must submit an application 
for a permit to import controlled substances on DEA Form 357. All 
applications and supporting materials must be submitted to the 
Administration through the DEA Office of Diversion Control secure 
network application. The application must be signed and dated by the 
importer and must contain the importer's registered address to which 
the controlled substances will be imported.
    (b) The applicant must include on the DEA Form 357 the registration 
number of the importer and a detailed description of each controlled 
substance to be imported including the drug name, dosage form, National 
Drug Code (NDC) number, the Administration Controlled Substance Code 
Number as set forth in part 1308 of this chapter, the number and size 
of the packages or containers, the name and quantity of the controlled 
substance contained in any finished dosage units, and the quantity of 
any controlled substance (expressed in anhydrous acid, base or 
alkaloid) given in kilograms or parts thereof. The application must 
also include the following:
    (1) The name/business name, address/business address, contact 
information (e.g., telephone number(s), email address(es), etc.), and 
business of the consignor, if known at the time the application is 
submitted, but if unknown at that time, the fact should be indicated 
and the name and address afterwards furnished to the Administration as 
soon as ascertained by the importer;
    (2) The foreign port and country of initial exportation (i.e., the 
place where the article will begin its journey of exportation to the 
United States);
    (3) The port of entry into the United States;
    (4) The latest date said shipment will leave said foreign port or 
country;
    (5) The stock on hand of the controlled substance desired to be 
imported;
    (6) The name of the importing carrier or vessel (if known, or if 
unknown it should be stated whether the shipment will be made by 
express, freight, or otherwise, imports of controlled substances in 
Schedules I or II and

[[Page 63614]]

narcotic drugs in Schedules III, IV, or V by mail being prohibited);
    (7) The total tentative allotment to the importer of such 
controlled substance for the current calendar year;
    (8) The total number of kilograms of said allotment for which 
permits have previously been issued and the total quantity of 
controlled substance actually imported during the current year to date.
    (c) If desired, alternative foreign ports of exportation within the 
same country may be indicated upon the application (e.g., 1. Kolkata, 
2. Mumbai). If a permit is issued pursuant to such application, it will 
bear the names of the two ports in the order given in the application 
and will authorize shipment from either port. Alternative ports in 
different countries will not be authorized in the same permit.
    (d) Return information. Within 30 calendar days after actual 
receipt of a controlled substance at the importer's registered 
location, or within 10 calendar days after receipt of a written request 
by the Administration to the importer, whichever is sooner, the 
importer must file a report with the Administration through the DEA 
Office of Diversion Control secure network application specifying the 
particulars of the transaction. This report must include the following 
information: The date the controlled substance was released by a 
customs officer at the port of entry); the date on which the controlled 
substance arrived at the registered location; the actual quantity of 
the controlled substance released by a customs officer at the port of 
entry; and the actual quantity of the controlled substance that arrived 
at the registered location. Upon receipt and review, the Administration 
will assign a transaction identification number to a completed report. 
The report will not be deemed filed until the Administration has issued 
a transaction identification number.
    (e) Denied release at the port of entry. In the event that a 
shipment of controlled substances has been denied release by a customs 
officer at the port of entry for any reason, the importer who attempted 
to have the shipment released must, within 24-hours of the denial, 
report to the Administration that the shipment was denied and the 
reason for denial. Such report must be transmitted to the 
Administration through the DEA Office of Diversion Control secure 
network application. This report must include the following 
information: The quantity of the controlled substance denied release; 
the date on which release was denied; and the basis for the denied 
release. Upon the importer's report of a denied release at the port of 
entry, the DEA will assign the report a transaction identification 
number and the import permit will be void and of no effect. No shipment 
of controlled substances denied release for any reason will be allowed 
to be released into the United States unless the importer submits a new 
DEA Form 357 and the Administration issues a new import permit.
0
45. Revise Sec.  1312.13(e) to read as follows:


Sec.  1312.13  Issuance of import permit.

* * * * *
    (e) If an importation is approved, the Administrator will issue an 
import permit bearing his or her signature or that of his or her 
delegate. Each permit will be assigned a unique permit number. A permit 
must not be altered or changed by any person after being signed. Any 
change or alteration upon the face of any permit after it has been 
signed renders it void and of no effect. Permits are not transferable. 
The Administrator or his/her delegate will date and certify on each 
permit that the importer named therein is thereby permitted as a 
registrant under the Act, to import, through the port of entry named, 
one shipment of not to exceed the specified quantity of the named 
controlled substances, shipment to be made before a specified date. 
Only one shipment may be made on a single import permit. Split 
shipments are prohibited. The permit must state that the Administration 
is satisfied that the consignment proposed to be imported is required 
for legitimate purposes.
* * * * *
0
46. Revise Sec.  1312.14 to read as follows:


Sec.  1312.14  Distribution of import permits.

    The Administration shall transmit the import permit to the 
competent national authority of the exporting country and shall make an 
official record of the import permit available to the importer through 
secure electronic means. The importer, or their agent, must submit an 
official record of the import permit and/or required data concerning 
the import transaction to a customs officer at the port of entry in 
compliance with all import control requirements of agencies with import 
control authorities under the Act or statutory authority other than the 
Controlled Substances Import and Export Act. The importer must maintain 
an official record of the import permit (available from the DEA Office 
of Diversion Control secure network application after issuance) in 
accordance with part 1304 of this chapter as the record of authority 
for the importation and shall transmit an official record of the permit 
to the foreign exporter. If required by the foreign competent national 
authority, the importer shall ensure that an official record of the 
import permit is provided (e.g., by transmitting an official record of 
the permit to the foreign exporter who shall transmit such record to 
the competent national authority of the exporting county). The importer 
must ensure that an official record of the permit accompanies the 
shipment of controlled substances to its final destination, the 
registered location of the importer (i.e., drop shipments are 
prohibited).


Sec.  1312.15  [Amended].

0
47. Amend Sec.  1312.15 as follows:
0
a. In paragraph (a), remove ``the U.S. Customs Service'' and add in its 
place ``the U.S. Customs and Border Protection or customs service of an 
Insular Area'', and add ``, in accordance with Sec.  1312.16(a)'' to 
the end of the first sentence; and
0
b. In paragraph (b), remove ``the U.S. Customs Service'' and add in its 
place ``the U.S. Customs and Border Protection or customs service of an 
Insular Area'', and remove ``Director of the Administration'' from the 
last sentence and add in its place ``Administrator''.
0
48. Revise Sec.  1312.16 to read as follows:


Sec.  1312.16  Amendment, cancellation, expiration of import permit.

    (a) Importers may only request that an import permit or application 
for an import permit be amended in accordance with paragraphs (a)(1) 
through (7) of this section. Requests for an amendment must be 
submitted through the DEA Office of Diversion Control secure network 
application. Except as provided in paragraph (a)(5) of this section and 
Sec.  1312.15(a), importers must submit all requests for an amendment 
at least one full business day in advance of the date of release by a 
customs officer. Importers must specifically request that an amendment 
be made; supplementary information submitted by an importer through the 
DEA Office of Diversion Control secure network application will not 
automatically trigger the amendment process. While the request for an 
amendment is being reviewed by the Administration, the original permit 
will be temporarily stayed and may not be used to authorize entry of a 
shipment of controlled substances. If the importer's request for an 
amendment to an issued permit is granted by the Administration, the 
Administration will immediately

[[Page 63615]]

cancel the original permit and re-issue the permit, as amended, with a 
revised permit number. The DEA and importer will distribute the amended 
permit in accordance with Sec.  1312.14. If a request for an amendment 
is denied by the Administration, the temporary stay will be lifted; 
once lifted, the originally issued permit may immediately be used to 
authorize entry of a shipment in accordance with the terms of the 
permit, subject to the shipment being compliant with all other 
applicable laws.
    (1) An importer may request that an import permit or application 
for a permit be amended to change the National Drug Control number, 
description of the packaging, or trade name of the product, so long as 
the description is for the same basic class of controlled substance as 
in the original permit.
    (2) An importer may request that an import permit or application 
for a permit be amended to change the proposed port of entry, the date 
of release by a customs officer, or the method of transport.
    (3) An importer may request that an import permit or application 
for a permit be amended to change the justification provided as to why 
an import shipment is needed to meet the legitimate scientific or 
medical needs of the United States.
    (4) An importer may request that an import permit or application 
for a permit be amended to change any registrant notes.
    (5) Prior to departure of the shipment from its original foreign 
location, an importer may request that an import permit or application 
for a permit be amended to increase the total base weight of a 
controlled substance. At the U.S. port of entry, an importer may 
request that an import permit be amended in accordance with Sec.  
1312.15(a). Importers are not required to amend an import permit for 
the sole purpose of decreasing the total base weight of a controlled 
substance authorized to be imported. However, the balance of any 
unimported authorized quantity of controlled substances on an import 
permit is void upon entry of a shipment on the issued permit or upon 
expiration of the unused permit in accordance with paragraph (b) of 
this section, whichever is sooner. Other than for an amendment to an 
import permit under Sec.  1312.15(a), importers must submit a request 
for an amendment to increase the total base weight of a controlled 
substance at least three business days in advance of the date of 
release by a customs officer.
    (6) An importer may request that an import permit be amended to 
remove a controlled substance from the permit. However, an importer may 
not amend an import permit to add or replace a controlled substance/
Administration controlled substance code number to the item(s) to be 
imported. Importers who desire to import a different controlled 
substance than that contained on their issued import permit or permit 
application must submit a request for the permit or permit application 
to be canceled and request a new permit in accordance with Sec.  
1312.12.
    (7) An importer may not amend the importer's name (as it appears on 
their DEA certificate of registration) or the name of the foreign 
exporter as provided in the DEA Form 357. Importers who need to make 
any changes to any of these fields must submit a request for the permit 
or permit application to be canceled and request a new permit in 
accordance with Sec.  1312.12.
    (b) An import permit will be void and of no effect after the 
expiration date specified therein, and in no event will the date be 
more than 180 calendar days after the date the permit is issued. 
Amended import permits will retain the original expiration date.
    (c) An import permit may be canceled after being issued, at the 
request of the importer submitted to the Administration through the DEA 
Office of Diversion Control secure network application, provided that 
no shipment has been made thereunder. Nothing in this part will affect 
the right, hereby reserved by the Administration, to cancel a permit at 
any time for proper cause.
0
49. In Sec.  1312.18:
0
a. Revise the section heading;
0
b. Revise paragraphs (b), (c) introductory text, and (c)(3); and
0
c. Add paragraphs (e) through (h);
    The revisions and additions read as follows:


Sec.  1312.18  Import declaration.

* * * * *
    (b) Any person registered or authorized to import and seeking to 
import any non-narcotic controlled substance listed in Schedules III, 
IV, or V which is not subject to the requirement of an import permit as 
described in paragraph (a) of this section, must file a controlled 
substances import declaration (DEA Form 236) with the Administration 
through the DEA Office of Diversion Control secure network application 
not later than 15 calendar days prior to the anticipated date of 
release by a customs officer and distribute an official record of the 
declaration as hereinafter directed in Sec.  1312.19. The declaration 
must be signed and dated by the importer and must specify the address 
of the final destination for the shipment, which must be the importer's 
registered location. Upon receipt and review, the Administration will 
assign a transaction identification number to each completed 
declaration. The import declaration is not deemed filed, and therefore 
is not valid, until the Administration has issued a transaction 
identification number. The importer may only proceed with the import 
transaction once the transaction identification number has been issued.
    (c) DEA Form 236 must include the following information:
* * * * *
    (3) The anticipated date of release by a customs officer at the 
port of entry, the foreign port and country of exportation to the 
United States, the port of entry, and the name, address, and 
registration number of the recipient in the United States; and
* * * * *
    (e) Return information. Within 30 calendar days after actual 
receipt of a controlled substance at the importer's registered 
location, or within 10 calendar days after receipt of a written request 
by the Administration to the importer, whichever is sooner, the 
importer must file a report with the Administration through the DEA 
Office of Diversion Control secure network application specifying the 
particulars of the transaction. This report must include the following 
information: The date on which the controlled substance was released by 
a customs officer at the port of entry; the date on which the 
controlled substance arrived at the registered location; the actual 
quantity of the controlled substance released by a customs officer at 
the port of entry; the actual quantity of the controlled substance that 
arrived at the registered location; and the actual port of entry. Upon 
receipt and review, the Administration will assign a transaction 
identification number to a completed report. The report will not be 
deemed filed until the Administration has issued a transaction 
identification number.
    (f) An importer may amend an import declaration in the same 
circumstances in which an importer may request amendment to an import 
permit, as set forth in Sec.  1312.16(a)(1) through (7). Amendments to 
declarations must be submitted through the DEA Office of Diversion 
Control secure network application. Except as provided in Sec.  
1312.16(a)(5) and Sec.  1312.15(a), importers must submit all 
amendments at least one full business day in advance of the date of 
release by a customs

[[Page 63616]]

officer. Importers must specifically note that an amendment is being 
made; supplementary information submitted by an importer through the 
DEA Office of Diversion Control secure network application will not 
automatically be considered an amendment. While the amendment is being 
processed by the Administration, the original declaration will be 
temporarily stayed and may not be used to authorize release of a 
shipment of controlled substances. Upon receipt and review, the 
Administration will assign each completed amendment a transaction 
identification number. The amendment will not be deemed filed until the 
Administration issues a transaction identification number. The DEA and 
importer will distribute the amended declaration in accordance with 
Sec.  1312.19. A filed amendment will not change the date that the 
declaration becomes void and of no effect pursuant to Sec.  1312.18(g).
    (g) An import declaration may be canceled after being filed with 
the Administration, at the request of the importer by the importer 
submitting to the Administration the request through the DEA Office of 
Diversion Control secure network application, provided that no shipment 
has been made thereunder. Import declarations shall become void and of 
no effect 180 calendar days after the date the declaration is deemed 
filed with the Administration.
    (h) Denied release at the port of entry. In the event that a 
shipment of controlled substances has been denied release by a customs 
officer at the port of entry for any reason, the importer who attempted 
to have the shipment released, within 24-hours of the denial, report to 
the Administration that the shipment was denied release and the reason 
for denial. Such report must be transmitted to the Administration 
through the DEA Office of Diversion Control secure network application. 
This report must include the following information: The quantity of the 
controlled substance denied release; the date on which release was 
denied; and the basis for the denied release. Upon the importer's 
report of a denied release, the DEA will assign the report a 
transaction identification number and the import declaration will 
become void and of no effect. No shipment of controlled substances 
denied release for any reason will be allowed to be released into the 
United States until the importer has filed a new import declaration and 
the Administration has issued a new transaction identification number.
0
50. Revise Sec.  1312.19 to read as follows:


Sec.  1312.19  Distribution of import declaration.

    The importer must furnish an official record of the declaration 
(available through the DEA Office of Diversion Control secure network 
application after the Administration issues a transaction 
identification number) to the foreign shipper. The foreign shipper must 
submit an official record of the declaration to the competent national 
authority of the exporting country, if required as a prerequisite to 
export authorization. The importer, or their agent, must submit an 
official record of the declaration and/or required data concerning the 
import transaction to a customs officer at the port of entry in 
compliance with all import control requirements of agencies with import 
control authorities under the Act or statutory authority other than the 
Controlled Substances Import and Export Act. The importer must ensure 
that an official record of the declaration accompanies the shipment to 
its final destination, which must only be the registered location of 
the importer (i.e., drop shipments are prohibited). The importer must 
maintain an official record of the declaration in accordance with part 
1304 of this chapter.
0
51. Revise Sec.  1312.21 to read as follows:


Sec.  1312.21   Requirement of authorization to export.

    (a) No person shall in any manner export, or cause to be exported, 
from the United States any controlled substance listed in Schedule I or 
II, or any narcotic controlled substance listed in Schedule III or IV, 
or any non-narcotic controlled substance in Schedule III which the 
Administrator has specifically designated by regulation in Sec.  
1312.30 or any non-narcotic controlled substance in Schedule IV or V 
which is also listed in Schedule I or II of the Convention on 
Psychotropic Substances, 1971, unless and until such person is properly 
registered under the Act (or, in accordance with part 1301 of this 
chapter, exempt from registration) and the Administrator has issued him 
or her a permit to do so in accordance with Sec.  1312.23.
    (b) No person shall in any manner export, or cause to be exported, 
from the United States any non-narcotic controlled substance listed in 
Schedule III, IV, or V, excluding those described in paragraph (a) of 
this section, or any narcotic controlled substance listed in Schedule 
V, unless and until such person is properly registered under the Act 
(or, in accordance with part 1301 of this chapter, exempt from 
registration) and has furnished an export declaration as provided by 
section 1003 of the Act (21 U.S.C. 953(e)) to the Administration in 
accordance with Sec.  1312.28.
    (c) A separate permit or declaration is required for each shipment 
of controlled substance to be exported.
0
52. Revise Sec.  1312.22 to read as follows:


Sec.  1312.22  Application for export or reexport permit; return 
information.

    (a) Registered exporters, and persons who in accordance with part 
1301 of this chapter are exempt from registration, seeking to export 
controlled substances must submit an application for a permit to export 
controlled substances on DEA Form 161. Registered exporters, and 
persons who in accordance with part 1301 of this chapter are exempt 
from registration, seeking to reexport controlled substances must 
submit an application for a permit to reexport controlled substances on 
DEA Form 161R or DEA Form 161R-EEA, whichever applies. All applications 
and supporting materials must be submitted to the Administration 
through the DEA Office of Diversion Control secure network application. 
The application must be signed and dated by the exporter and contain 
the exporter's registered address from which the controlled substances 
will be exported. Controlled substances may not be exported until a 
permit number has been issued.
    (b) Exports of controlled substances by mail are prohibited.
    (c) Applications. (1) Except as provided in paragraph (c)(2) of 
this section, each application for a permit to export or reexport must 
include the following information:
    (i) The exporter's name/business name, address/business address, 
and contact information (e.g., telephone number(s), email address(es), 
etc.);
    (ii) The exporter's registration number, address, and contact 
information (e.g., telephone number(s), etc.) from which the controlled 
substances will be exported;
    (iii) A detailed description of each controlled substance to be 
exported including the drug name, dosage form, National Drug Code (NDC) 
number, Administration Controlled Substance Code Number as set forth in 
part 1308 of this chapter, the number and size of the packages or 
containers, the name and quantity of the controlled substance contained 
in any finished dosage units, and the quantity of any controlled 
substance (expressed in anhydrous acid,

[[Page 63617]]

base, or alkaloid) given in kilograms or parts thereof;
    (iv) The name/business name, address/business address, contact 
information (e.g., telephone number(s), email address(es), etc.) and 
business of the consignee in the first country (the country to which 
the controlled substance is exported from the United States), foreign 
port and country of entry/first country of entry, the port of export, 
the anticipated date of release by a customs officer at the port of 
export, the name of the exporting carrier or vessel (if known, or if 
unknown it should be stated whether the shipment will be made by 
express, freight, or otherwise), the date and number, if any, of the 
supporting foreign import license or permit accompanying the 
application, and the authority by whom such foreign license or permit 
was issued;
    (v) An affidavit that the packages or containers are labeled in 
conformance with obligations of the United States under international 
treaties, conventions, or protocols in effect at the time of the export 
or reexport. The affidavit shall further state that to the best of the 
affiant's knowledge and belief, the controlled substances therein are 
to be applied exclusively to medical or scientific uses within the 
country to which exported, will not be reexported therefrom and that 
there is an actual need for the controlled substance for medical or 
scientific uses within such country, unless the application is 
submitted for reexport in accordance with paragraphs (f) through (h) of 
this section. In the case of exportation of crude cocaine, the 
affidavit may state that to the best of affiant's knowledge and belief, 
the controlled substances will be processed within the country to which 
exported, either for medical or scientific use within that country or 
for reexportation in accordance with the laws of that country to 
another for medical or scientific use within that country;
    (2) With respect to reexports among members of the European 
Economic Area in accordance with section 1003(f) of the Act (21 U.S.C. 
953(f)), the requirements of paragraph (c)(1) of this section shall 
apply only with respect to the export from the United States to the 
first country and not to any subsequent export from that country to 
another country of the European Economic Area.
    (d)(1) Except as provided in paragraph (d)(2) of this section, the 
applicant must also submit with the application any import license or 
permit or a certified copy of any such license or permit issued by the 
competent national authority in the country of destination, or other 
documentary evidence deemed adequate by the Administration, showing: 
that the merchandise is consigned to an authorized permittee; that it 
is to be applied exclusively to medical or scientific use within the 
country of destination; that it will not be reexported from such 
country (unless the application is submitted for reexport in accordance 
with paragraphs (f) through (h) of this section); and that there is an 
actual need for the controlled substance for medical or scientific use 
within such country or countries. If the import license or permit, or 
the certified copy of such, is not written in English or bilingual with 
another language and English, the registrant must also submit with 
their application a certified translation of the permit or license. For 
purposes of this requirement, certified translation means that the 
translator has signed the translation legally attesting the accuracy of 
the translation and the attestation has been notarized. (In the case of 
exportation of bulk coca leaf alkaloid, the applicant need only include 
with the application the material outlined in paragraph (c) of this 
section.)
    (2) With respect to reexports among members of the European 
Economic Area in accordance with section 1003(f) of the Act (21 U.S.C. 
953(f)), the requirements of paragraph (d)(1) of this section shall 
apply only with respect to the export from the United States to the 
first country and not to any subsequent export from that country to 
another country of the European Economic Area.
    (e) Return information for exports (on a DEA Form 161). Within 30 
calendar days after the controlled substance is released by a customs 
officer at the port of export, or within 10 calendar days after receipt 
of a written request by the Administration to the exporter, whichever 
is sooner, the exporter must report to the Administration through the 
DEA Office of Diversion Control secure network application the 
particulars of the transaction. This report must include the following 
information: the date on which the controlled substance left the 
registered location; the date on which the controlled substance was 
released by a customs officer at the port of export); the actual 
quantity of controlled substance that left the registered location; and 
the actual quantity of the controlled substance released by a customs 
officer at the port of export; the actual port of export, and any other 
information as the Administration may from time to time specify. Upon 
receipt and review, the Administration will assign a transaction 
identification number to a completed report. The report will not be 
deemed filed until the Administration has issued a transaction 
identification number.
    (f) Reexports outside of the European Economic Area. Except as 
provided in paragraph (g), the Administration may authorize any 
controlled substance listed in Schedule I or II, or any narcotic drug 
listed in Schedule III or IV, to be exported from the United States to 
a country for subsequent export from that country to another country, 
if each of the following conditions is met, in accordance with section 
1003(f) of the Act (21 U.S.C. 953(f)):
    (1) Both the country to which the controlled substance is exported 
from the United States (referred to in this section as the ``first 
country'') and the country to which the controlled substance is 
exported from the first country (referred to in this section as the 
``second country'') are parties to the Single Convention on Narcotic 
Drugs, 1961, and the Convention on Psychotropic Substances, 1971;
    (2) The first country and the second country have each instituted 
and maintain, in conformity with such Conventions, a system of controls 
of imports of controlled substances which the Administration deems 
adequate;
    (3) With respect to the first country, the controlled substance is 
consigned to a holder of such permits or licenses as may be required 
under the laws of such country, and a permit or license to import the 
controlled substance has been issued by the country;
    (4) With respect to the second country, substantial evidence is 
furnished to the Administration by the applicant for the export permit 
that--
    (i) The controlled substance is to be consigned to a holder of such 
permits or licenses as may be required under the laws of such country, 
and a permit or license to import the controlled substance is to be 
issued by the country; and
    (ii) The controlled substance is to be applied exclusively to 
medical, scientific, or other legitimate uses within the country;
    (5) The controlled substance will not be exported from the second 
country;
    (6) The exporter has complied with paragraph (h) of this section 
and a permit to export the controlled substance from the United States 
has been issued by the Administration; and
    (7) Return information for reexports outside of the European 
Economic Area (on DEA Form 161R)--(i) Return information for export 
from the United States, for reexport. Within 30 calendar days after the 
controlled substance is released by a customs officer at the port of 
export the exporter must file a report

[[Page 63618]]

with the Administration through the DEA Office of Diversion Control 
secure network application specifying the particulars of the 
transaction. This report must include the following information: the 
date on which the controlled substance left the registered location; 
the date on which the controlled substance was released by a customs 
officer at the port of export; the actual quantity of controlled 
substance released by a customs officer at the port of export; and the 
actual port of export. Upon receipt and review, the Administration will 
assign a completed report a transaction identification number. The 
report will not be deemed filed until the Administration has issued a 
transaction identification number. In determining whether the exporter 
has complied with the requirement to file within 30 calendar days, the 
report shall be deemed filed on the first date on which a complete 
report is filed.
    (ii) Return information for export from a first country that is or 
is not a member of the European Economic Area to a country outside of 
the European Economic Area; return information for export from a first 
country that is not a member of the European Economic Area to a member 
of the European Economic Area. Within 30 calendar days after the 
controlled substance is exported from the first country to the second 
country the exporter must file a report with the Administration through 
the DEA Office of Diversion Control secure network application 
specifying the particulars of the export from the first country. If the 
permit issued by the Administration authorized the reexport of a 
controlled substance from the first country to more than one second 
country, a report for each individual reexport is required. These 
reports must include the following information: name of second country; 
actual quantity of controlled substance shipped; and the date shipped 
from the first country, the actual port from which the controlled 
substances were shipped from the first country. Upon receipt and 
review, the Administration will assign each completed report a 
transaction identification number. The report will not be deemed filed 
until the Administration has issued a transaction identification 
number.
    (g) Reexports among members of the European Economic Area (on DEA 
Form 161R-EEA). The Administration may authorize any controlled 
substance listed in Schedule I or II, or any narcotic drug listed in 
Schedule III or IV, to be exported from the United States to a country 
of the European Economic Area for subsequent export from that country 
to another country of the European Economic Area, if the following 
conditions and the conditions of (f)(1), (2), (3) (4), and (6) are met, 
in accordance with section 1003(f) of the Act (21 U.S.C. 953(f)):
    (1)(i) The controlled substance will not be exported from the 
second country, except that the controlled substance may be exported 
from a second country that is a member of the European Economic Area to 
another country that is a member of the European Economic Area, 
provided that the first country is also a member of the European 
Economic Area; and
    (ii) Subsequent to any reexportation described in paragraph 
(g)(1)(i) of this section, a controlled substance may continue to be 
exported from any country that is a member of the European Economic 
Area to any other such country, if--
    (A) The conditions applicable with respect to the first country 
under paragraphs (f)(1), (2), (3), (4), and (6) of this section and 
paragraph (g)(2) of this section are met with respect to each 
subsequent country from which the controlled substance is exported 
pursuant to this paragraph; and
    (B) The conditions applicable with respect to the second country 
under paragraphs (f)(1), (2), (3), (4), and (6) of this section and 
paragraph (g)(2) of this section are met with respect to each 
subsequent country to which the controlled substance is exported 
pursuant to this paragraph.
    (2) Return information for reexports among members of the European 
Economic Area--(i) Return information for export from the United 
States, for reexport among members of the European Economic Area. 
Exporters must comply with the return reporting requirements of 
paragraph (f)(7)(i) of this section.
    (ii) Reexports among members of the European Economic Area. Within 
30 calendar days after the controlled substance is exported from the 
first country to the second country, and within 30 calendar days of 
each subsequent reexport within the European Economic Area, if any, the 
U.S. exporter must file a report with the Administration through the 
DEA Office of Diversion Control secure network application specifying 
the particulars of the export. These reports must include the name of 
country to which the controlled substance was reexported, i.e., another 
member of the European Economic Area; the actual quantity of controlled 
substance shipped; the date shipped from the first country, the name/
business name, address/business address, contact information (e.g., 
telephone number(s), email address(es), etc.) and business of the 
consignee; and the name/business name, address/business address, 
contact information (e.g., telephone number(s), email address(es), 
etc.) and business of the exporter. Upon receipt and review, the 
Administration will assign each completed report a transaction 
identification number. The report will not be deemed filed until the 
Administration has issued a transaction identification number.
    (h) Where a person is seeking to export a controlled substance for 
reexport outside of the European Economic Area in accordance with 
paragraph (f) of this section, the requirements of paragraphs (h)(1) 
through (7) of this section shall apply in addition to (and not in lieu 
of) the requirements of paragraphs (a) through (d) of this section. 
Where a person is seeking to export a controlled substance for reexport 
among members of the European Economic Area in accordance with 
paragraph (g) of this section, the requirements of paragraph (h)(4) of 
this section shall apply in addition to (and not in lieu of) the 
requirements of paragraphs (a) through (d) of this section.
    (1) Bulk substances will not be reexported in the same form as 
exported from the United States, i.e., the material must undergo 
further manufacturing process. This further manufactured material may 
only be reexported to a second country.
    (2) Finished dosage units, if reexported, must be in a commercial 
package, properly sealed and labeled for legitimate medical use in the 
second country.
    (3) Any proposed reexportation must be made known to the 
Administration at the time the initial DEA Form 161R is submitted. In 
addition, the following information must also be provided where 
indicated on the form:
    (i) Whether the drug or preparation will be reexported in bulk or 
finished dosage units;
    (ii) The product name, dosage strength, commercial package size, 
and quantity;
    (iii) The name of consignee, complete address, and expected 
shipment date, as well as the name and address of the ultimate 
consignee in the second country.
    (4) The application must contain an affidavit that the consignee in 
the second country, and any country of subsequent reexport within the 
European Economic Area, is authorized under the laws and regulations of 
the second and/or subsequent country to receive the controlled 
substances. The

[[Page 63619]]

affidavit must also contain the following statements, in addition to 
the statements required under paragraph (c) of this section:
    (i) That the packages are labeled in conformance with the 
obligations of the United States under the Single Convention on 
Narcotic Drugs, 1961, the Convention on Psychotropic Substances, 1971, 
and any amendments to such treaties in effect;
    (ii) That the controlled substances are to be applied exclusively 
to medical or scientific uses within the second country, or country of 
subsequent reexport within the European Economic Area;
    (iii) That the controlled substances will not be further reexported 
from the second country except as provided by paragraph (f) of section 
1003 of the Act (21 U.S.C. 953(f)); and
    (iv) That there is an actual need for the controlled substances for 
medical or scientific uses within the second country, or country of 
subsequent reexport within the European Economic Area.
    (5) If the applicant proposes that the shipment of controlled 
substances will be separated into parts after it arrives in the first 
country and then reexported to more than one second country, the 
applicant must so indicate on the DEA Form 161R and provide all the 
information required in this section for each second country.
    (6) Except in the case of reexports among countries of the European 
Economic Area in accordance with section 1003(f) of the Act (21 U.S.C. 
953(f)), the controlled substance will be reexported from the first 
country to the second country (or second countries) no later than 180 
calendar days after the controlled substance was released by a customs 
officer from the United States.
    (7) Shipments that have been exported from the United States and 
are refused by the consignee in either the first or second country, or 
subsequent member of the European Economic Area, or are otherwise 
unacceptable or undeliverable, may be returned to the registered 
exporter in the United States upon authorization of the Administration. 
In these circumstances, the exporter in the United States must submit a 
written request for the return of the controlled substances to the 
United States with a brief summary of the facts that warrant the 
return, along with a completed DEA Form 357 through the DEA Office of 
Diversion Control secure network application. The Administration will 
evaluate the request after considering all the facts as well as the 
exporter's registration status with the Administration. If the exporter 
provides sufficient justification, the Administration may issue an 
import permit for the return of these drugs, and the exporter may then 
obtain an export permit from the country of original importation. The 
substance may not be returned to the United States until after a permit 
has been issued by the Administration.
    (i) In considering whether to grant an application for a permit 
under paragraphs (f) through (h) of this section, the Administration 
shall consider whether the applicant has previously obtained such a 
permit and, if so, whether the applicant complied fully with the 
requirements of this section with respect to that previous permit.
    (j) Denied release at the port of export. In the event that a 
shipment of controlled substances has been denied release by a customs 
officer at the port export from the United States for any reason, the 
exporter who attempted to have the shipment released must, within 24-
hours of the denial, report to the Administration that the shipment was 
denied release and the reason for denial. Such report must be 
transmitted to the Administration through the DEA Office of Diversion 
Control secure network application. This report must include the 
following information: The quantity of the controlled substance denied 
release; the date on which release was denied; the basis for the denied 
release, the port from which the denial was issued, and any other 
information as the Administration may from time to time specify. Upon 
the exporter's report of a denied release, DEA will assign the report a 
transaction identification number and the export permit will be void 
and of no effect. No shipment of controlled substances denied release 
for any reason will be allowed to be released from the United States 
unless the exporter submits a new DEA Form 161, 161R, or 161R-EEA, as 
appropriate, and the Administration issues a new export permit.
0
53. Revise Sec.  1312.23(e) to read as follows:


Sec.  1312.23  Issuance of export permit.

* * * * *
    (e) If an exportation is approved, the Administrator shall issue an 
export permit bearing his or her signature or that of his or her 
delegate. Each permit will be assigned a permit number that is a 
unique, randomly generated identifier. A permit shall not be altered or 
changed by any person after being signed. Any change or alteration upon 
the face of any permit after it has been signed renders it void and of 
no effect. Permits are not transferable. The Administrator or his/her 
delegate shall date and certify on each permit that the exporter named 
therein is thereby permitted as a registrant under the Act, to export, 
through the port of export named, one shipment of not to exceed the 
specified quantity of the named controlled substances, shipment to be 
made before a specified date. Only one shipment may be made on a single 
export permit. Split shipments are prohibited. Each export permit shall 
be predicated upon, inter alia, an import certificate or other 
documentary evidence issued by a foreign competent national authority.
* * * * *
0
54. Revise Sec.  1312.24 to read as follows:


Sec.  1312.24  Distribution of export permit.

    The Administration shall transmit the export permit to the 
competent national authority of the importing country and shall make 
available to the exporter an official record of the export permit 
through secure electronic means. The exporter, or their agent, must 
submit an official record of the export permit and/or required data 
concerning the export transaction to a customs officer at the port of 
export in compliance with all export control requirements of agencies 
with export control authorities under the Act or statutory authority 
other than the Controlled Substances Import and Export Act. The 
exporter must maintain an official record of the export permit 
(available from the secure network application on the DEA Office of 
Diversion Control Web site after the Administration issues a 
transaction identification number) in accordance with part 1304 of this 
chapter as the record of authority for the exportation and shall 
transmit an official record of the export permit to the foreign 
importer. The exporter must ensure that an official record of the 
permit accompanies the shipment to its final destination. No shipment 
of controlled substances denied release for any reason shall be allowed 
to be released from the United States without subsequent authorization 
from the Administration.
0
55. Revise Sec.  1312.25 to read as follows:


Sec.  1312.25  Amendment, cancellation, expiration of export permit.

    (a) Exporters may only request that an export permit or application 
for an export permit be amended in accordance with paragraphs (a)(1) 
through (7) of this section. Requests for an amendment must be 
submitted through the DEA Office of Diversion Control secure network 
application. Except as provided in paragraph (a)(5)

[[Page 63620]]

of this section exporters must submit all requests for an amendment at 
least one full business day in advance of the date of release from the 
port of export. Exporters must specifically request that an amendment 
be made; supplementary information submitted by an exporter through the 
DEA Office of Diversion Control secure network application will not 
automatically trigger the amendment process. While the request for an 
amendment is being reviewed by the Administration, the original permit 
will be temporarily stayed and may not be used to authorize release of 
a shipment of controlled substances. If the exporter's request for an 
amendment to an issued permit is granted by the Administration, the 
Administration will immediately cancel the original permit and re-issue 
the permit, as amended, with a revised permit number. The DEA and 
exporter will distribute the amended permit in accordance with Sec.  
1312.24. If a request for an amendment is denied by the Administration, 
the temporary stay will be lifted; once lifted, the originally issued 
permit may immediately be used to authorize release of a shipment in 
accordance with the terms of the permit.
    (1) An exporter may request that an export permit or application 
for a permit be amended to change the National Drug Control number, 
description of the packaging, or trade name of the product, so long as 
the description is for the same basic class of controlled substance as 
in the original permit.
    (2) An exporter may request that an export permit or application 
for a permit be amended to change the proposed port of export, the 
anticipated date of release by a customs officer, or the method of 
transport.
    (3) An exporter may request that an export permit or application 
for a permit be amended to change the justification provided as to why 
an export shipment is needed to meet the legitimate scientific or 
medical needs of the country of import.
    (4) An exporter may request that an export permit or application 
for a permit be amended to change any registrant notes.
    (5) Prior to departure of the shipment from the exporter's 
registered location, an exporter may request that an export permit or 
application for a permit be amended to increase the total base weight 
of a controlled substance. However, the total base weight or the 
strength of the product (if listed) of a controlled substance may not 
exceed that permitted for import as indicated on the import permit from 
the foreign competent national authority. Exporters are not required to 
amend an export permit for the sole purpose of decreasing the total 
base weight of a controlled substance authorized to be exported. 
However, the balance of any unexported authorized quantity of 
controlled substances on an export permit is void upon release of a 
shipment on the issued permit or upon expiration of the unused permit 
in accordance with paragraph (b) of this section, whichever is sooner. 
Exporters must submit a request for an amendment to increase the total 
base weight of a controlled substance at least three business days in 
advance of the date of release from the port of export.
    (6) An exporter may request that an export permit be amended to 
remove a controlled substance from the permit. However, an exporter may 
not amend an export permit to add or replace a controlled substance to 
the item(s) to be exported. Exporters who desire to export a different 
controlled substance than that contained on their issued export permit 
or permit application must submit a request for the permit or permit 
application to be canceled and request a new permit in accordance with 
Sec.  1312.22.
    (7) An exporter may not amend the exporter's name (as it appears on 
their DEA certificate of registration), the name of the foreign 
importer(s), or the foreign permit information as provided in the DEA 
Form 161, 161R, or 161R-EEA. Exporters who need to make any changes to 
any of these fields must submit a request for the permit or permit 
application to be canceled and request a new permit in accordance with 
Sec.  1312.22.
    (b) An export permit will be void and of no effect after the date 
specified therein, which date must conform to the expiration date 
specified in the supporting import certificate or other documentary 
evidence upon which the export permit is founded, but in no event will 
the date be more than 180 calendar days after the date the permit is 
issued.
    (c) An export permit may be canceled after being issued, at the 
request of the exporter submitted to the Administration through the DEA 
Office of Diversion Control secure network application, provided that 
no shipment has been made thereunder. Nothing in this part will affect 
the right, hereby reserved by the Administration, to cancel an export 
permit at any time for proper cause.
0
56. Revise Sec.  1312.26 to read as follows:


Sec.  1312.26   Records required of exporter.

    In addition to any other records required by this chapter, the 
exporter must keep a record of any serial numbers that might appear on 
packages of narcotic drugs in quantities of one ounce or more in such a 
manner as will identify the foreign consignee, along with an official 
record of the export permit, in accordance with part 1304 of this 
chapter.
0
57. In Sec.  1312.27:
0
a. Revise the section heading and paragraphs (a) and (b); and
0
b. Add paragraphs (d) through (g);
    The revisions and additions read as follows:


Sec.  1312.27  Export/reexport declaration.

    (a) Any person registered or authorized to export and seeking to 
export any non-narcotic controlled substance listed in Schedule III, 
IV, or V, which is not subject to the requirement of an export permit 
pursuant to Sec.  1312.23(b) or (c), or any person registered or 
authorized to export and seeking to export any controlled substance in 
Schedule V, must file a controlled substances export declaration (DEA 
Form 236) with the Administration through the DEA Office of Diversion 
Control secure network application not less than 15 calendar days prior 
to the anticipated date of release by a customs officer at the port of 
export, and distribute an official record of the declaration as 
hereinafter directed in Sec.  1312.28. The declaration must be signed 
and dated by the exporter and must contain the address of the 
registered location from which the substances will be shipped for 
exportation. Upon receipt and review, the Administration will issue a 
completed declaration a transaction identification number. The export 
declaration is not deemed filed, and therefore not valid, until the 
Administration has issued a transaction identification number. The 
exporter may only proceed with the export transaction once the 
transaction identification number has been issued.
    (b)(1) DEA Form 236 must include the following information:
    (i) The name/business name, address/business address, contact 
information (e.g., telephone number(s), email address(es), etc.), and 
registration number, if any, of the exporter; and the name/business 
name, address/business address, contact information (e.g., telephone 
number(s), email address(es), etc.), and registration number of the 
export broker, if any;
    (ii) A detailed description of each controlled substance to be 
exported including the drug name, dosage form, National Drug Code (NDC) 
number, Administration Controlled Substance Code Number as set forth in 
part 1308

[[Page 63621]]

of this chapter, the number and size of the packages or containers, the 
name and quantity of the controlled substance contained in any finished 
dosage units, and the quantity of any controlled substance (expressed 
in anhydrous acid, base, or alkaloid) given in kilograms or parts 
thereof; and
    (iii) The anticipated date of release by a customs officer at the 
port of export, the port of export, the foreign port and country of 
entry, the carriers and shippers involved, method of shipment, the name 
of the vessel if applicable, and the name, address, and registration 
number, if any, of any forwarding agent utilized; and
    (iv) The name/business name, address/business address, and contact 
information (e.g., telephone number(s), email address(es), etc.) of the 
consignee in the country of destination, and any registration or 
license number if the consignee is required to have such numbers either 
by the country of destination or under United States law. In addition, 
documentation must be provided to show that:
    (A) The consignee is authorized under the laws and regulations of 
the country of destination to receive the controlled substances, and 
that
    (B) The substance is being imported for consumption within the 
importing country to satisfy medical, scientific or other legitimate 
purposes, and that
    (v) The reexport of non-narcotic controlled substances in Schedules 
III and IV, and controlled substances in Schedule V is not permitted 
under the authority of 21 U.S.C. 953(e), except as provided below and 
in paragraph (b)(1)(vi) of this section:
    (A) Bulk substances will not be reexported in the same form as 
exported from the United States, i.e, the material must undergo further 
manufacturing process. This further manufactured material may only be 
reexported to a country of ultimate consumption.
    (B) Finished dosage units, if reexported, will be in a commercial 
package, properly sealed and labeled for legitimate medical use in the 
country of destination.
    (C) Any reexportation be made known to DEA at the time the initial 
DEA Form 236, Controlled Substances Import/Export Declaration is 
completed, by checking the box marked ``other'' on the certification. 
The following information will be furnished in the remarks section:
    (1) Indicate ``for reexport''.
    (2) Indicate if reexport is bulk or finished dosage units.
    (3) Indicate product name, dosage strength, commercial package 
size, and quantity.
    (4) Indicate name of consignee, complete address, and expected 
shipment date, as well as, the name and address of the ultimate 
consignee in the country to where the substances will be reexported.
    (5) A statement that the consignee in the country of ultimate 
destination is authorized under the laws and regulations of the country 
of ultimate destination to receive the controlled substances.
    (D) Shipments that have been exported from the United States and 
are refused by the consignee in either the first or second country, or 
subsequent member of the European Economic Area, or are otherwise 
unacceptable or undeliverable, may be returned to the registered 
exporter in the United States upon authorization of the Administration. 
In this circumstance, the exporter in the United States must file a 
written request for reexport, along with a completed DEA Form 236, with 
the Administration through the DEA Office of Diversion Control secure 
network application. A brief summary of the facts that warrant the 
return of the substance to the United States along with an 
authorization from the country of export must be included with the 
request. DEA will evaluate the request after considering all the facts 
as well as the exporter's registration status with DEA. The substance 
may be returned to the United States only after affirmative 
authorization is issued in writing by DEA.
    (vi) The reexport of non-narcotic controlled substances in 
Schedules III and IV, and controlled substances in Schedule V is 
permitted among members of the European Economic Area only as provided 
below:
    (A) The controlled substance will not be exported from the second 
country or a subsequent country, except that the controlled substance 
may be exported from a second country or a subsequent country that is a 
member of the European Economic Area to another country that is a 
member of the European Economic Area, provided that the first country 
is also a member of the European Economic Area; each country is a party 
to the Convention on Psychotropic Substances, 1971, as amended; and 
each country has instituted and maintains, in conformity with such 
Convention, a system of controls of imports of controlled substances 
which the Attorney General deems adequate.
    (B) Each shipment of finished dosage units, if reexported, must be 
in a commercial package, properly sealed and labeled for legitimate 
medical use in the country of destination.
    (C) Any reexportation must be made known to DEA at the time the 
initial DEA Form 236, Controlled Substances Import/Export Declaration 
is completed, by checking the box marked ``other'' on the 
certification. In addition to the requirements of paragraph (b) of this 
section, the following information will be furnished in the remarks 
section:
    (1) Indicate ``for reexport among members of the European Economic 
Area''.
    (2) Indicate if reexport is bulk or finished dosage units.
    (3) Indicate product name, dosage strength, commercial package 
size, and quantity.
    (4) Indicate the name/business name, address/business address, 
contact information (e.g., telephone number(s), email address(es) and 
business of the consignee in the first country.
    (5) A statement that the consignee in the second country, and any 
subsequent consignee within the European Economic Area, is authorized 
under the laws and regulations of the second and/or subsequent country 
to receive the controlled substances.
    (2) With respect to reexports among members of the European 
Economic Area, the requirements of paragraph (b)(1) of this section 
shall apply only with respect to the export from the United States to 
the first country and not to any subsequent export from that country to 
another country of the European Economic Area.
* * * * *
    (d) Return information--(i) Return information for exports. Within 
30 calendar days after the controlled substance is released by a 
customs officer at the port of export, or within 10 calendar days after 
receipt of a written request by the Administration to the exporter, 
whichever is sooner, the exporter must file a report with the 
Administration through the DEA Office of Diversion Control secure 
network application specifying the particulars of the transaction. This 
report must include the following information: The date on which the 
controlled substance left the registered location; the date on which 
the controlled substance was released by a customs officer; the actual 
quantity of the controlled substance that left the registered location; 
and the actual quantity of the controlled substance released by a 
customs officer at the port of export; the actual port of export. Upon 
receipt and review, the Administration will assign a completed report a 
transaction identification number. The report will not be deemed filed 
until the Administration has issued a transaction identification 
number.

[[Page 63622]]

    (ii) Return information for reexports outside of the European 
Economic Area--(A) Return information for export from the United 
States, for reexport. Within 30 calendar days after the controlled 
substance is released by a customs officer at the port of export the 
exporter must file a report with the Administration through the DEA 
Office of Diversion Control secure network application specifying the 
particulars of the transaction. This report must include the following 
information: The date on which the controlled substance left the 
registered location; the date on which the controlled substance was 
released by a customs officer at the port of export; the actual 
quantity of controlled substance released by a customs officer at the 
port of export; and the actual port of export. Upon receipt and review, 
the Administration will assign a completed report a transaction 
identification number. The report will not be deemed filed until the 
Administration has issued a transaction identification number.
    (B) Return information for export from a first country that is or 
is not a member of the European Economic Area to a country outside of 
the European Economic Area; return information for export from a first 
country that is not a member of the European Economic Area to a member 
of the European Economic Area. Within 30 calendar days after the 
controlled substance is exported from the first country to the second 
country the exporter must file a report with the Administration through 
the DEA Office of Diversion Control secure network application 
specifying the particulars of the export from the first country. If the 
permit issued by the Administration authorized the reexport of a 
controlled substance from the first country to more than one second 
country, a report for each individual reexport is required. These 
reports must include the following information: Name of second country; 
actual quantity of controlled substance shipped; the date shipped from 
the first country; and the actual port from which the controlled 
substances were shipped from the first country. Upon receipt and 
review, the Administration will assign each completed report a 
transaction identification number. The report will not be deemed filed 
until the Administration has issued a transaction identification 
number.
    (iii) Reexports among members of the European Economic Area--(A) 
Return information for exports from the United States, for reexport 
among members of the European Economic Area. Exporters must comply with 
the return reporting requirements of paragraph (d)(ii)(A) of this 
section.
    (B) Reexports among members of the European Economic Area. Within 
30 calendar days after the controlled substance is exported from the 
first country to the second country, and within 30 calendar days of 
each subsequent reexport within the European Economic Area, if any, the 
exporter must file a report with the Administration through the DEA 
Office of Diversion Control secure network application specifying the 
particulars of the export. These reports must include the name of 
country to which the controlled substance was reexported to another 
member of the European Economic Area; the actual quantity of controlled 
substance shipped; the date shipped from the first country, the name/
business name, address/business address, contact information (e.g., 
telephone number(s), email address(es), etc.) and business of the 
consignee; and the name/business name, address/business address, 
contact information (e.g., telephone number(s), email address(es), 
etc.) and business of the exporter. Upon receipt and review, the 
Administration will assign each completed report a transaction 
identification number. The report will not be deemed filed until the 
Administration has issued a transaction identification number.
    (e) An exporter may amend an export declaration in the same 
circumstances in which an exporter may request amendment to an export 
permit, as set forth in Sec.  1312.25(a)(1) through (7). Amendments to 
declarations must be submitted through the DEA Office of Diversion 
Control secure network application. Except as provided in Sec.  
1312.25(a)(5) exporters must submit all amendments at least one full 
business day in advance of the date of release by a customs officer. 
Exporters must specifically note that an amendment is being made; 
supplementary information submitted by an exporter through the DEA 
Office of Diversion Control secure network application will not 
automatically be considered an amendment. Upon receipt and review, the 
Administration will assign each completed amendment a transaction 
identification number. The amendment will not be deemed filed until the 
Administration issues a transaction identification number. The DEA and 
the exporter will distribute the amended declaration in accordance with 
Sec.  1312.28. A filed amendment will not change the date that the 
declaration becomes void and of no effect in accordance with Sec.  
1312.27(f).
    (f) An export declaration may be canceled after being filed with 
the Administration, at the request of the exporter, provided no 
shipment has been made thereunder. Export declarations shall become 
void and of no effect 180 calendar days after the date the declaration 
is deemed filed with the Administration.
    (g) Denied release at the port of export. In the event that a 
shipment of controlled substances has been denied release by a customs 
officer at the port of export for any reason, the exporter who 
attempted to have the shipment released must, within 24-hours of the 
denial, report to the Administration that the shipment was denied 
release and the reason for denial. Such report must be transmitted to 
the Administration through the DEA Office of Diversion Control secure 
network application. This report must include the following 
information: The quantity of the controlled substance denied release; 
the date on which release was denied; and the basis for the denied 
release. Upon the exporter's report of a denied release, DEA will 
assign the report a transaction identification number and the export 
declaration will be void and of no effect. No shipment of controlled 
substances denied release for any reason will be allowed to be released 
unless the exporter files a new declaration and the Administration 
issues a new transaction identification number.
0
58. Revise Sec.  1312.28 to read as follows:


Sec.  1312.28   Distribution of export declaration.

    (a) The exporter must ensure that an official record of the export 
declaration (available from the DEA Office of Diversion Control secure 
network application after the Administration issues a transaction 
identification number) accompanies the shipment of controlled 
substances to its destination.
    (b) The exporter, or their agent, must submit an official record of 
the export declaration and/or required data concerning the export 
transaction to a customs officer at the port of export in compliance 
with all export control requirements of agencies with export control 
authorities under the Act or statutory authority other than the 
Controlled Substances Import and Export Act.
    (c) The exporter must maintain an official record of the export 
declaration and return information (both available from the Office of 
Diversion Control secure network application after the Administration 
issues a transaction identification number) required pursuant to Sec.  
1312.27(d) as his or her

[[Page 63623]]

record of authority for the exportation, in accordance with part 1304 
of this chapter.
0
59. In Sec.  1312.31, revise introductory text of paragraph (b) and add 
paragraph (d)(4) to read as follows:


Sec.  1312.31  Schedule I: Application for prior written approval.

* * * * *
    (b) An application for a transshipment permit must be submitted to 
the Regulatory Section, Office of Diversion Control, Drug Enforcement 
Administration, at least 30 calendar days, or in the case of an 
emergency as soon as is practicable, prior to the expected date of 
arrival at the first port in the United States. See the Table of DEA 
Mailing Addresses in Sec.  1321.01 of this chapter for the current 
mailing address. A separate permit is required for each shipment of 
controlled substance to be imported, transferred, or transshipped. Each 
application must contain the following:
* * * * *
    (d) * * *
    (4) If the import license or permit, or the certified copy of such, 
is not written in English or bilingual with another language and 
English, the application must include a certified translation of the 
permit or license. For purposes of this requirement, certified 
translation means that the translator has signed the translation 
legally attesting the accuracy of the translation and the attestation 
has been notarized.
* * * * *
0
60. Revise Sec.  1312.32 to read as follows:


Sec.  1312.32   Schedules II, III, IV: Advance notice.

    (a) A controlled substance listed in Schedules II, III, or IV may 
be imported into the United States for transshipment, or may be 
transferred or transshipped within the United States for immediate 
exportation, provided that written notice is submitted to the 
Regulatory Section, Office of Diversion Control, Drug Enforcement 
Administration, at least 15 calendar days prior to the expected date of 
date of arrival at the first port in the United States. See the Table 
of DEA mailing Addresses in Sec.  1321.01 of this chapter for the 
current mailing addresses.
    (b) A separate advance notice is required for each shipment of 
controlled substance to be imported, transferred, or transshipped. Each 
advance notice must contain those items required by Sec.  1312.31(b) 
and (c). If the export license, permit, or other authorization, issued 
by a competent national authority of the country of origin, is not 
written in English or bilingual with another language and English, the 
notice must be accompanied by a certified translation of the export 
license, permit, or other authorization. For purposes of this 
requirement, certified translation means that the translator has signed 
the translation legally attesting the accuracy of the translation and 
the attestation has been notarized.

PART 1313--IMPORTATION AND EXPORTATION OF LIST I AND LIST II 
CHEMICALS

0
61. The authority citation for part 1313 continues to read as follows:

    Authority: 21 U.S.C. 802, 830, 871(b), 971.

0
62. Add Sec.  1313.03 to read as follows:


Sec.  1313.03  Forms applicable to this part.

------------------------------------------------------------------------
                   Form                          Access/ submission
------------------------------------------------------------------------
DEA Form 486, Import/Export Declaration     electronic.
 for List I and List II Chemicals.
DEA Form 486A Import Declaration for        electronic.
 ephedrine, pseudoephedrine, and
 phenylpropanolamine (including drug
 products containing these chemicals).
------------------------------------------------------------------------

0
63. In Sec.  1313.12, revise the section heading, paragraphs (a), (b), 
(c) introductory text (d), and (e) introductory text to read as 
follows:


Sec.  1313.12  Notification prior to import.

    (a) Each regulated person who seeks to import a listed chemical 
that meets or exceeds the threshold quantities identified in Sec.  
1310.04(f) of this chapter or is a listed chemical for which no 
threshold has been established as identified in Sec.  1310.04(g) of 
this chapter, must notify the Administration of the intended import by 
filing an import declaration (on DEA Form 486/486A) not later than 15 
calendar days before the date of release by a customs officer at the 
port of entry. Regulated persons who seek to import a listed chemical 
below the threshold quantities identified in Sec.  1310.04(f) of this 
chapter are not required to file an import declaration in advance of 
the release by a customs officer.
    (b) A complete and accurate declaration (DEA Form 486/486A) must be 
filed with the Administration through the DEA Office of Diversion 
Control secure network application not later than 15 calendar days 
prior to the date of release by a customs officer at the port of entry. 
The declaration must be signed and dated by the importer and must 
contain the address of the final destination for the shipment, which 
for List I chemicals must be a registered location of the importer. 
Upon receipt and review, the Administration will assign a transaction 
identification number to each completed declaration. The 15 calendar 
days shall begin on the date that the regulated person submits a 
completed declaration, without regard to the date that the 
Administration assigns a transaction identification number. Listed 
chemicals meeting or exceeding the threshold quantities identified in 
Sec.  1310.04(f) of this chapter or for which no threshold has been 
established may not be imported until a transaction identification 
number has been issued.
    (c) The 15-calendar-day advance notification requirement for listed 
chemical imports may be waived, in whole or in part, for the following:
* * * * *
    (d) For imports meeting the requirements of paragraph (c)(1) of 
this section, the declaration (DEA Form 486/486A) must be filed with 
the Administration through the DEA Office of Diversion Control secure 
network application at least three business days before the date of 
release by a customs officer at the port of entry. The declaration must 
be signed and dated by the importer and must contain the address of the 
final destination for the shipment, which must be a registered location 
of the importer (for List I chemicals). Upon receipt and review, the 
Administration will assign a transaction identification number to each 
completed declaration. The importer may proceed with the import 
transaction only once the transaction identification number has been 
issued.
    (e) For importations where advance notification is waived pursuant 
to paragraph (c)(2) of this section no DEA Form 486 is required; 
however, the regulated person must submit quarterly reports to the 
Regulatory Section, Office of Diversion Control, Drug Enforcement 
Administration, not later than the 15th day of the month following the 
end of each quarter. See the Table of DEA Mailing Addresses in Sec.  
1321.01 of this chapter for the current mailing address. The report 
shall contain the following information regarding each individual 
importation:
* * * * *
0
64. Revise Sec.  1313.13 to read as follows:


Sec.  1313.13   Requirements of import declaration.

    (a) Any List I or List II chemical listed in Sec.  1310.02 of this 
chapter may be imported if that chemical is necessary for medical, 
commercial, scientific, or other legitimate uses within the United

[[Page 63624]]

States. Chemical importations into the United States for immediate 
transfer/transshipment outside the United States must comply with the 
procedures set forth in Sec.  1313.31 and all other applicable laws.
    (b) The DEA Form 486/486A must include the following information:
    (1) The name/business name, address/business address, and contact 
information (e.g., telephone number(s), email address(es), etc.) of the 
chemical importer; the name/business name, address/business address, 
and contact information (e.g., telephone number(s), email address(es), 
etc.) of the broker or forwarding agent (if any); and
    (2) The name and description of each listed chemical as it appears 
on the label or container, the name of each chemical as it is 
designated in Sec.  1310.02 of this chapter, the size or weight of 
container, the number of containers, the net weight of each listed 
chemical given in kilograms or parts thereof, and the gross weight of 
the shipment given in kilograms or parts thereof; and
    (3) The date of release by a customs officer at the port of entry, 
the foreign port and country of export, and the port of entry; and
    (4) The name/business name, address/business address, and contact 
information (e.g., telephone number(s), email address(es), etc.) of the 
consignor in the foreign country of exportation; and
    (5) The name/business name, address/business address, and contact 
information (e.g., telephone number(s), email address(es), etc.) of the 
person or persons to whom the importer intends to transfer the listed 
chemical and the quantity to be transferred to each transferee.
    (c) Any regulated person importing ephedrine, pseudoephedrine, or 
phenylpropanolamine must submit, on the import declaration (DEA Form 
486A), all information known to the importer on the chain of 
distribution of the chemical from the manufacturer to the importer. 
Ephedrine, pseudoephedrine, or phenylpropanolamine include each of the 
salts, optical isomers, and salts of optical isomers of the chemical.
    (d) Import declarations shall become void and of no effect 180 
calendar days after the date the declaration is deemed filed with the 
Administration.
0
65. Revise Sec.  1313.14 to read as follows:


Sec.  1313.14  Disposition of import declaration.

    The importer, or their agent, must submit an official record of the 
import declaration and/or required data concerning the import 
transaction to a customs officer at the port of entry in compliance 
with all import control requirements of agencies with import control 
authorities under the Act or statutory authority other than the 
Controlled Substances Import and Export Act. The final destination of 
the import transaction must only be the registered location of the 
importer (i.e., drop shipments are prohibited). A regulated person must 
maintain an official record of the declaration (available from the DEA 
Office of Diversion Control secure network application after the 
Administration issues a transaction identification number) in 
accordance with part 1310 of this chapter as the record of the import. 
Official records of import declarations involving listed chemicals must 
be retained for two years.
0
66. In Sec.  1313.15, revise the section heading and paragraph (b) to 
read as follows:


Sec.  1313.15   Qualification of regular importers.

* * * * *
    (b) Each regulated person making application under paragraph (a) of 
this section shall be considered a ``regular importer'' 30 calendar 
days after receipt of the application by the Administration, as 
indicated on the return receipt, unless the regulated person is 
otherwise notified in writing by the Administration.
* * * * *
0
67. In Sec.  1313.16, revise the section heading and paragraph (b) to 
read as follows:


Sec.  1313.16   Updated notice for change in circumstances.

* * * * *
    (b) After a notice under Sec.  1313.12(a) or (d) is submitted to 
the Administration, if circumstances change and the importer will not 
be transferring the listed chemical to the transferee identified in the 
notice, or will be transferring a greater quantity of the chemical than 
specified in the notice, the importer must update the notice to 
identify the most recent prospective transferee or the most recent 
quantity or both (as the case may be) and may not transfer the listed 
chemical until after the expiration of the 15-calendar-day period 
beginning on the date on which the update is filed with the 
Administration, or, if the import is being made by a regular importer 
or intended for transfer to a regular customer, 3 business days. The 
preceding sentence applies with respect to changing circumstances 
regarding a transferee or quantity identified in an update to the same 
extent and in the same manner as the sentence applies with respect to 
changing circumstances regarding a transferee or quantity identified in 
the original notice under Sec.  1313.12(a) or (d). Amended declarations 
must be submitted to the Administration through the DEA Office of 
Diversion Control secure network application. The amendment must be 
signed and dated by the importer. Upon receipt and review, the 
Administration will assign each completed amendment a transaction 
identification number. Such shipment of listed chemicals may not be 
imported into the United States until the transaction identification 
number has been issued.
* * * * *
0
68. Revise Sec.  1313.17 to read as follows:


Sec.  1313.17  Return declaration for imports.

    (a) Return information. Within 30 calendar days after actual 
receipt of a listed chemical at the importer's registered location or 
place of business if not required to be registered, the importer must 
file a report with the Administration through the DEA Office of 
Diversion Control secure network application specifying the particulars 
of the transaction. This report must include the following information: 
The date on which the the listed chemical was released by a customs 
officer at the port of entry; the date on which the listed chemical 
arrived at the importer's registered location or place of business; the 
actual quantity of the listed chemical released; the actual quantity of 
the listed chemical that arrived at the importer's location; the date 
of any subsequent transfer; a description of the subsequent transfer, 
including the actual quantity transferred, chemical, container, and 
name of transferees; the actual port of entry; and any other 
information as the Administration may specify. A single report may 
include the particulars of both the importation and distribution. If 
the importer has not distributed all chemicals imported by the end of 
the initial 30-calendar-day period, the importer must file supplemental 
reports not later than 30 calendar days from the date of any further 
distribution, until the distribution or other disposition of all 
chemicals imported under the import declaration or any amendment or 
other update is accounted for. Upon receipt and review, the 
Administration will assign each completed report a transaction 
identification number. In determining whether the importer has complied 
with the requirement to file within 30 calendar days, the report shall

[[Page 63625]]

be deemed filed on the first date on which a complete report is filed.
    (b) If an importation for which a DEA Form 486/486A has been filed 
fails to take place, the importer must report to the Administration 
that the importation did not occur through the DEA Office of Diversion 
Control secure network application.
    (c) Denied release at the port of entry. In the event that a 
shipment of listed chemicals has been denied release by a customs 
officer at the port of entry for any reason, the importer who attempted 
to have the shipment released, within 24-hours of the denial, report to 
the Administration that the shipment was denied release and the reason 
for denial. Such report must be transmitted to the Administration 
through the DEA Office of Diversion Control secure network application. 
This report must include the following information: the quantity of the 
listed chemical denied release; the date on which release was denied; 
and the basis for the denied release. Upon the importer's report of a 
denied release, the DEA will assign the report a transaction 
identification number and the import declaration will be void and of no 
effect. No shipment of listed chemicals denied release for any reason 
will be allowed entry into the United States without a subsequent 
refiling of an import declaration. Following such refiling the importer 
may request release of the listed chemicals immediately after receipt 
of a transaction identification number without regard to the 15 day 
advance filing requirement in Sec.  1313.12(b).
0
69. In Sec.  1313.21, revise the section heading, paragraphs (a), (b), 
(c) introductory text, (d), and (e) introductory text, and add 
paragraph (h) to read as follows:


Sec.  1313.21   Notification prior to export.

    (a) Each regulated person who seeks to export a listed chemical 
that meets or exceeds the threshold quantities identified in Sec.  
1310.04(f) of this chapter, or is a listed chemical for which no 
threshold has been established as identified in Sec.  1310.04(g) of 
this chapter, must notify the Administration of the intended export by 
filing an export declaration (DEA Form 486) not later than 15 calendar 
days before the date of release by a customs officer at the port of 
export. Regulated persons who seek to export a listed chemical below 
the threshold quantities identified in Sec.  1310.04(f) of this chapter 
are not required to file an export declaration in advance of the 
export.
    (b) A complete and accurate declaration (DEA Form 486) must be 
filed with the Administration through the DEA Office of Diversion 
Control secure network application not later than 15 calendar days 
prior to the date of release by a customs officer at the port of 
export. The declaration must be signed and dated by the exporter and 
must contain the address from which the listed chemicals will be 
shipped for exportation. Upon receipt and review, the Administration 
will assign a transaction identification number to each completed 
declaration. The 15 calendar days shall begin on the date that the 
regulated person files a completed declaration without regard to the 
date that the Administration assigns a transaction identification 
number. Exporters may not request release of a listed chemical until a 
transaction identification number has been issued.
    (c) The 15-calendar-day advance notification requirement for listed 
chemical exports may be waived, in whole or in part, for:
* * * * *
    (d) For exports meeting the requirements of paragraph (c)(1) of 
this section, the declaration (DEA Form 486) must be filed with the 
Administration through the DEA Office of Diversion Control secure 
network application at least three business days before the date of 
release by a customs officer. The declaration must be signed and dated 
by the exporter and must contain the address from which the listed 
chemicals will be shipped for exportation. Upon receipt and review, the 
Administration will assign a transaction identification number to each 
completed declaration. The exporter may only proceed with the export 
transaction once the transaction identification number has been issued.
    (e) For exportations where advance notification is waived pursuant 
to paragraph (c)(2) of this section no DEA Form 486 is required; 
however, the regulated person must submit quarterly reports with the 
Regulatory Section, Office of Diversion Control, Drug Enforcement 
Administration, not later than the 15th day of the month following the 
end of each quarter. See the Table of DEA Mailing Addresses in Sec.  
1321.01 of this chapter for the current mailing address. Such report 
shall contain the following information regarding each individual 
exportation:
* * * * *
    (h) Export declarations shall become void and of no effect 180 
calendar days after the date the declaration is deemed filed with the 
Administration.
0
70. Revise Sec.  1313.22 to read as follows:


Sec.  1313.22   Export declaration.

    (a) Any List I or List II chemical listed in Sec.  1310.02 of this 
chapter which meets or exceeds the quantitative threshold criteria 
established in Sec.  1310.04(f) of this chapter or is a listed chemical 
for which no threshold has been established as identified in Sec.  
1310.04(g) of this chapter, may be exported if that chemical is needed 
for medical, commercial, scientific, or other legitimate uses.
    (b) The export declaration (DEA Form 486) must include all the 
following information:
    (1) The name/business name, address/business address, and contact 
information (e.g., telephone number(s), email address(es), etc.) of the 
chemical exporter; the name/business name, address/business address, 
and contact information (e.g., telephone number(s), email address(es), 
etc.) of the export broker, if any;
    (2) The name and description of each listed chemical as it appears 
on the label or container, the name of each listed chemical as it is 
designated in Sec.  1310.02 of this chapter, the size or weight of 
container, the number of containers, the net weight of each listed 
chemical given in kilograms or parts thereof, and the gross weight of 
the shipment given in kilograms or parts thereof;
    (3) The anticipated date of release by a customs officer at the 
port of export, the port of export, and the foreign port and country of 
entry; and
    (4) The name/business name, address/business address, and contact 
information (e.g., telephone number(s), email address(es), etc.) of the 
consignee in the country where the chemical shipment is destined; the 
name(s) and address(es) of any intermediate consignee(s); and a copy of 
the foreign permit, license or registration issued by the competent 
national authority of the consignee and any intermediate consignees.
    (c) Declared exports of listed chemicals which are refused, 
rejected, or otherwise deemed undeliverable by the foreign competent 
national authority may be returned to the U.S. chemical exporter of 
record. The regulated person must provide notification through the DEA 
Office of Diversion Control secure network application (this does not 
require a DEA Form 486) outlining the circumstances within a reasonable 
time following the return. Upon receipt and review, the Administration 
will assign the completed notice a transaction identification number. 
The notice will not be deemed filed until the Administration issues a 
transaction identification number. Listed chemicals so returned may not 
be reexported until the exporter has filed a new DEA Form 486 and the 
Administration has issued a new transaction identification

[[Page 63626]]

number. This provision does not apply to shipments that have cleared 
foreign customs, been delivered, and accepted by the foreign consignee. 
Returns to third parties in the United States will be regarded as 
imports.
0
71. Revise Sec.  1313.23 to read as follows:


Sec.  1313.23  Disposition of export declaration.

    The exporter, or their agent, must submit an official record of the 
export declaration and/or required data concerning the export 
transaction to a customs officer at the port of export in compliance 
with all export control requirements of agencies with export control 
authorities under the Act or statutory authority other than the 
Controlled Substances Import and Export Act. An official record of the 
declaration (available from the DEA Office of Diversion Control secure 
network application after the Administration issues a transaction 
identification number) must be maintained by the chemical exporter as 
the official record of the export in accordance with part 1310 of this 
chapter. Export declarations involving a listed chemical must be 
retained for two years.
0
72. In Sec.  1313.26, revise the section heading and paragraph (b) to 
read as follows:


Sec.  1313.26  Updated notice for change in circumstances.

* * * * *
    (b) After a notice under Sec.  1313.21(a) is submitted to the 
Administration, if circumstances change and the exporter will not be 
transferring the listed chemical to the transferee identified in the 
notice, or will be transferring a greater quantity of the chemical than 
specified in the notice, the exporter must update the notice to 
identify the most recent prospective transferee or the most recent 
quantity or both (as the case may be). The exporter may not transfer 
the listed chemical until after the expiration of the 15-calendar-day 
period beginning on the date on which the update is filed with the 
Administration. Except, if the listed chemical is intended for transfer 
to a regular customer, the exporter may not transfer the listed 
chemical until after the expiration ofthree business days. The 
preceding sentence applies with respect to changing circumstances 
regarding a transferee or quantity identified in an update to the same 
extent and in the same manner as the sentence applies with respect to 
changing circumstances regarding a transferee or quantity identified in 
the original notice under paragraph (a) of this section. Amended 
declarations must be submitted to the Administration through the DEA 
Office of Diversion Control secure network application. The amendment 
must be signed and dated by the exporter. Upon receipt and review, the 
Administration will assign each completed amendment a transaction 
identification number. The amendment will not be deemed filed until the 
Administration issues a transaction identification number.
* * * * *
0
73. Revise Sec.  1313.27 to read as follows:


Sec.  1313.27  Return declaration for exports.

    (a) Return information. Within 30 calendar days after a listed 
chemical is released by a customs officer at the port of export, the 
exporter must file a report with the Administration through the DEA 
Office of Diversion Control secure network application specifying the 
particulars of the transaction. This report must include the following 
information: the date on which the listed chemical left the registered 
location or place of business; the date on which the listed chemical 
was released by a customs officer at the port of export; the actual 
quantity of listed chemical that left the registered location or place 
of business; the actual quantity of the listed chemical released by a 
customs officer at the port of export; chemical; container; name of 
transferees; and any other information as the Administration may 
specify. Upon receipt and review, the Administration will assign a 
completed report a transaction identification number. The report will 
not be deemed filed until the Administration has issued a transaction 
identification number. In determining whether the exporter has complied 
with the requirement to file within 30 calendar days, the report shall 
be deemed filed on the first date on which a complete report is filed.
    (b) If an exportation for which a DEA Form 486 has been filed fails 
to take place, the exporter must report to the Administration that the 
exportation did not occur through the DEA Office of Diversion Control 
secure network application.
    (c) Denied release at the port of export. In the event that a 
shipment of listed chemicals has been denied release by a customs 
officer at the port of export for any reason, the exporter who 
attempted to have the shipment released must, within 24-hours of the 
denial, report to the Administration that the shipment was denied 
release and the reason for denial. Such report must be transmitted to 
the Administration through the DEA Office of Diversion Control secure 
network application. This report must include the following 
information: the quantity of the listed chemicals denied release; the 
date on which release was denied; and the basis for the denied release. 
Upon the exporter's report of a denied release, DEA will assign the 
report a transaction identification number and the export declaration 
will be void and of no effect. No shipment of listed chemicals denied 
release for any reason will be allowed to be released from the United 
States without a subsequent refiling of a complete and accurate export 
declaration. Following such refiling, the exporter may request the 
release of the listed chemicals immediately after receipt of a 
transaction identification number without regard to the 15 day advance 
filing required by paragraph Sec.  1313.21(b).
0
74. In Sec.  1313.31, revise paragraph (b) introductory text and 
paragraphs (b)(7), (b)(8), (b)(14), and (b)(15) to read as follows:


Sec.  1313.31  Advance notice of importation for transshipment or 
transfer.

* * * * *
    (b) Advance notification must be provided to the Regulatory 
Section, Office of Diversion Control, Drug Enforcement Administration, 
not later than 15 calendar days prior to the proposed date the listed 
chemical will transship or transfer through the United States. See the 
Table of DEA Mailing Addresses in Sec.  1321.01 of this chapter for the 
current mailing address. A separate notification is required for each 
shipment of listed chemicals to be transferred or transshipped. The 
written notification (not a DEA Form 486) must contain the following 
information:
* * * * *
    (7) The name/business name, address/business address, and contact 
information (e.g., telephone number(s), email address(es), etc.) and 
type of business of the foreign exporter;
    (8) The foreign port and country of export;
* * * * *
    (14) The name/business name, address/business address, and contact 
information (e.g., telephone number(s), email address(es), etc.) and 
type of business of the consignee at the foreign port or country of 
entry;
    (15) The shipping route from the U.S. port of export to the foreign 
port or country of entry at final destination;
* * * * *
0
75. Revise Sec.  1313.32 to read as follows:

[[Page 63627]]

Sec.  1313.32  Notification of international transactions.

    (a) A broker or trader must notify the Administration prior to an 
international transaction involving a listed chemical which meets or 
exceeds the threshold quantities identified in Sec.  1310.04(f) of this 
chapter or is a listed chemical for which no threshold has been 
established as identified in Sec.  1310.04(g) of this chapter, in which 
the broker or trader participates. Notification must be made not later 
than 15 calendar days before the transaction is to take place. In order 
to facilitate an international transaction involving listed chemicals 
and implement the purpose of the Act, regulated persons may wish to 
provide advance notification to the Administration as far in advance of 
the 15 calendar days as possible.
    (b) A completed DEA Form 486 must be submitted to the 
Administration through the DEA Office of Diversion Control secure 
network application, not later than 15 calendar days prior to the 
international transaction. The DEA Form 486 must be signed and dated by 
the broker or trader. Upon receipt and review, the Administration will 
assign a transaction identification number to each completed 
notification. A notification is not deemed filed, and therefore is not 
valid, until the Administration assigns the notification a transaction 
identification number. An international transaction may not take place 
until after a transaction identification number has been assigned and 
the expiration of the 15-calendar-day period beginning on the date on 
which the broker or trader submits a complete notification to the 
Administration.
    (c) No person shall serve as a broker or trader for an 
international transaction involving a listed chemical knowing or having 
reasonable cause to believe that the transaction is in violation of the 
laws of the country to which the chemical is exported or the chemical 
will be used to manufacture a controlled substance in violation of the 
laws of the country to which the chemical is exported. The 
Administration will publish a notice of foreign import restrictions for 
listed chemicals of which DEA has knowledge as provided in Sec.  
1313.25.
    (d) After a notice under paragraph (a) of this section is submitted 
to the Administration, if circumstances change and the broker or trader 
will not be transferring the listed chemical to the transferee 
identified in the notice, or will be transferring a greater quantity of 
the chemical than specified in the notice, the broker or trader must 
amend the notice through the DEA Office of Diversion Control secure 
network application to identify the most recent prospective transferee 
or the most recent quantity or both (as applicable) and may not 
transfer the listed chemical until after the expiration of the 15-
calendar-day period beginning on the date on which the update is 
submitted to the Administration. The preceding sentence applies with 
respect to changing circumstances regarding a transferee or quantity 
identified in an amendment to the same extent and in the same manner as 
the sentence applies with respect to changing circumstances regarding a 
transferee or quantity identified in the original notice under 
paragraph (a) of this section.
    (e) For purposes of this section:
    (1) The term transfer, with respect to a listed chemical, includes 
the sale of the chemical.
    (2) The term transferee means a person to whom an exporter 
transfers a listed chemical.
0
76. Revise Sec.  1313.33(b) and (c) to read as follows:


Sec.  1313.33  Contents of an international transaction declaration.

* * * * *
    (b) Any broker or trader who desires to arrange an international 
transaction, defined in 21 U.S.C. 802(42), involving a listed chemical 
which meets the threshold criteria set forth in Sec.  1310.04 of this 
chapter must notify the Administration through the procedures outlined 
in Sec.  1313.32(b).
    (c) The DEA Form 486 must include:
    (1) The name/business name, address/business address, and contact 
information (e.g., telephone number(s), email address(es), etc.) of the 
chemical exporter; the name/business name, address/business address, 
and contact information (e.g., telephone number(s), email address(es), 
etc.) of the chemical importer;
    (2) The name and description of each listed chemical as it appears 
on the label or container, the name of each listed chemical as it is 
designated in Sec.  1310.02 of this chapter, the size or weight of 
container, the number of containers, the net weight of each listed 
chemical given in kilograms or parts thereof, and the gross weight of 
the shipment given in kilograms or parts thereof;
    (3) The anticipated date of release at the foreign port of export, 
the anticipated foreign port and country of export, and the foreign 
port and country of entry; and
    (4) The name/business name, address/business address, and contact 
information (e.g., telephone number(s), email address(es), etc.) of the 
consignee in the country where the chemical shipment is destined; the 
name(s) and address(es) of any intermediate consignee(s).
0
77. Revise Sec.  1313.34 to read as follows:


Sec.  1313.34  Disposition of the international transaction 
declaration.

    The broker or trader must retain an official record of the 
declaration (DEA Form 486) (available from the DEA Office of Diversion 
Control secure network application after the Administration issues a 
transaction identification number) as the official record of the 
international transaction. In accordance with part 1310 of this 
chapter, declarations involving listed chemicals must be retained for 
two years.
0
78. Revise Sec.  1313.35 to read as follows:


Sec.  1313.35   Return declaration or amendment to Form 486 for 
international transactions.

    (a) Within 30 calendar days after an international transaction is 
completed, the broker or trader must file a report with the 
Administration through the DEA Office of Diversion Control secure 
network application about the particulars of the transaction. This 
report must include the following information: the date(s) on which the 
listed chemical was released by the foreign customs officer(s) at the 
port(s); the actual quantity of listed chemical that left the country 
of export; the actual quantity of the listed chemical released by a 
customs officer at the port of entry; chemical; container; name of 
transferees; and the transaction identification and any other 
information as the Administration may specify. Upon receipt and review, 
the Administration will assign a completed report a transaction 
identification number. The report will not be deemed filed until the 
Administration has issued a transaction identification number.
    (b) If an international transaction for which a DEA Form 486 has 
been filed fails to take place, the broker or trader must report to the 
Administration that the international transaction did not occur 
utilizing the DEA Office of Diversion Control secure network 
application as soon as the broker or trader becomes aware of the 
circumstances.

PART 1314--RETAIL SALE OF SCHEDULED LISTED CHEMICAL PRODUCTS

0
79. The authority citation for part 1314 continues to read as follows:


[[Page 63628]]


    Authority: 21 U.S.C. 802, 830, 842, 871(b), 875, 877, 886a.


Sec.  1314.110  [Amended]

0
80. In Sec.  1314.110, in paragraphs (a)(1) and (2), remove the phrase 
``Import/Export Unit,'' and add in its place ``Regulatory Section, 
Office of Diversion Control,''.

PART 1315--IMPORTATION AND PRODUCTION QUOTAS FOR EPHEDRINE, 
PSEUDOEPHEDRINE, AND PHENYLPROPANOLAMINE

0
81. The authority citation for part 1315 continues to read as follows:

    Authority: 21 U.S.C. 802, 821, 826, 871(b), 952.


Sec.  1315.22   [Amended]

0
82. In Sec.  1315.22, remove ``Drug & Chemical Evaluation Section, Drug 
Enforcement Administration'' from the second sentence of the 
introductory text and add in its place ``UN Reporting & Quota Section, 
Office of Diversion Control, Drug Enforcement Administration''.


Sec.  1315.27   [Amended]

0
83. In Sec.  1315.27, remove ``Drug & Chemical Evaluation Section'' and 
add in its place ``UN Reporting & Quota Section, Office of Diversion 
Control, Drug Enforcement Administration''.


Sec.  1315.32   [Amended]

0
84. In Sec.  1315.32(e) and (g), remove ``Drug & Chemical Evaluation 
Section, Drug Enforcement Administration'' wherever it appears and add 
in its place ``UN Reporting & Quota Section, Office of Diversion 
Control, Drug Enforcement Administration''.


Sec.  1315.34   [Amended]

0
85. In Sec.  1315.34(d), remove ``Drug & Chemical Evaluation Section'' 
from the second sentence and add in its place ``UN Reporting & Quota 
Section, Office of Diversion Control, Drug Enforcement 
Administration''.


Sec.  1315.36   [Amended]

0
86. In Sec.  1315.36(b), remove ``Drug & Chemical Evaluation Section, 
Drug Enforcement Administration'' from the second sentence and add in 
its place ``UN Reporting & Quota Section, Office of Diversion Control, 
Drug Enforcement Administration''.

PART 1316--ADMINISTRATIVE FUNCTIONS, PRACTICES, AND PROCEDURES

0
87. The authority citation for part 1316, subpart D continues to read 
as follows:

    Authority: 21 U.S.C. 811, 812, 871(b), 875, 958(d), 965.

0
88. Revise Sec.  1316.47(a) to read as follows:


Sec.  1316.47   Request for hearing.

    (a) Any person entitled to a hearing and desiring a hearing shall, 
within the period permitted for filing, file a request for a hearing 
and/or an answer that complies with the following format (see the Table 
of DEA Mailing Addresses in Sec.  1321.01 of this chapter for the 
current mailing address):

(Date)-----------------------------------------------------------------
Drug Enforcement Administration, Attn: Hearing Clerk/OALJ
(Mailing Address)------------------------------------------------------
Subject: Request for Hearing
Dear Hearing Clerk:
    The undersigned___(Name of the Person) hereby requests a hearing in 
the matter of:___(Identification of the proceeding).
    (A) (State with particularity the interest of the person in the 
proceeding.)
    (B) (State with particularity the objections or issues, if any, 
concerning which the person desires to be heard.)
    (C) (State briefly the position of the person with regard to the 
particular objections or issues.)
    All notices to be sent pursuant to the proceeding should be 
addressed to:
(Name)-----------------------------------------------------------------
(Street Address)-------------------------------------------------------
(City and State)-------------------------------------------------------
Respectfully yours,
(Signature of Person)--------------------------------------------------
* * * * *
0
89. Revise Sec.  1316.48 to read as follows:


Sec.  1316.48   Notice of appearance.

    Any person entitled to a hearing and desiring to appear in any 
hearing, shall, if he or she has not filed a request for hearing, file 
within the time specified in the notice of proposed rulemaking, a 
written notice of appearance in the following format (see the Table of 
DEA Mailing Addresses in Sec.  1321.01 of this chapter for the current 
mailing address):
(Date)-----------------------------------------------------------------
Drug Enforcement Administration, Attn: Hearing Clerk/OALJ
(Mailing Address)------------------------------------------------------
Subject: Notice of Appearance
Dear Hearing Clerk:
    Please take notice that___(Name of person) will appear in the 
matter of:___(Identification of the proceeding).
    (A) (State with particularity the interest of the person in the 
proceeding.).
    (B) (State with particularity the objections or issues, if any, 
concerning which the person desires to be heard.).
    (C) (State briefly the position of the person with regard to the 
particular objections or issues.).
    All notices to be sent pursuant to this appearance should be 
addressed to:
(Name)-----------------------------------------------------------------
(Street Address)-------------------------------------------------------
(City and State)-------------------------------------------------------
    Respectfully yours,
(Signature of Person)--------------------------------------------------

PART 1321--DEA MAILING ADDRESSES

0
90. The authority citation for part 1321 continues to read:

    Authority:  21 U.S.C. 871(b).
0
91. Revise Sec.  1321.01 to read as follows:


Sec.  1321.01   DEA mailing addresses.

    The following table provides information regarding mailing 
addresses to be used when sending specified correspondence to the Drug 
Enforcement Administration.

                     Table of DEA Mailing Addresses
------------------------------------------------------------------------
 Code of Federal Regulations Section--
                 Topic                         DEA mailing address
------------------------------------------------------------------------
                            DEA Administrator
------------------------------------------------------------------------
1308.43(b)--Petition to initiate         Drug Enforcement
 proceedings for rulemaking.              Administration, Attn:
1316.23(b)--Petition for grant of         Administrator, 8701
 confidentiality for research subjects.   Morrissette Drive,
1316.24(b)--Petition for exemption from   Springfield, VA 22152.
 prosecution for researchers..
------------------------------------------------------------------------

[[Page 63629]]

 
                     DEA Office of Diversion Control
------------------------------------------------------------------------
1307.03--Exception request filing.       Drug Enforcement
1307.22--Delivery of surrendered and      Administration, Attn: Office
 forfeited controlled substances..        of Diversion Control/OD, 8701
1310.21(b)--Sale by Federal departments   Morrissette Drive,
 or agencies of chemicals which could     Springfield, VA 22152.
 be used to manufacture controlled
 substances certification request.**.
------------------------------------------------------------------------
                         DEA Regulatory Section
------------------------------------------------------------------------
1301.71(d)--Security system compliance   Drug Enforcement
 review for controlled substances.        Administration, Attn:
1309.71(c)--Security system compliance    Regulatory Section/ODG, 8701
 review for List I chemicals.             Morrissette Drive,
                                          Springfield, VA 22152.
1310.03(c)--Mail-Order reports
 involving transactions with
 nonregulated persons or exports.*
1310.05(b)(1)--Unusual or excessive
 loss or disappearance of listed
 chemicals
1310.05(b)(2)--Reports of domestic
 regulated transactions in a tableting
 machine or an encapsulating machine.*
1310.05(c)(1)--Reports of imports and
 exports of a tableting machine or an
 encapsulating machine.*
1310.05(c)(2)--Report of declared
 exports of machines refused, rejected,
 or returned.
1312.12(a)--Application for import
 permit (DEA Form 357).*
1312.18(b)--Import declaration (DEA
 Form 236) submission.*
1312.22(g)(8)--Request for return of
 unacceptable or undeliverable exported
 controlled substances.*
1312.27(a)--Controlled substances
 export declaration (DEA Form 236)
 filing.*
1312.31(b)--Controlled substances
 transshipment permit application.
1312.32(a)--Advanced notice of
 importation for transshipment or
 transfer of controlled substances.
1313.12(b)--Authorization to import
 listed chemicals (DEA Form 486/486A).*
1313.12(e)--Quarterly reports of listed
 chemicals importation.
1313.21(b)--Authorization to export
 listed chemicals (DEA Form 486).*
1313.21(e)--Quarterly reports of listed
 chemicals exportation.
1313.22(c)--Notice of declared exports
 of listed chemicals refused, rejected
 or undeliverable.*
1313.31(b)--Advanced notice of
 importation for transshipment or
 transfer of listed chemicals.
1313.32(b)(1)--International
 transaction authorization (DEA Form
 486).*
1314.110(a)(1)--Reports for mail-order
 sales.
1314.110(a)(2)--Request to submit mail-
 order sales reports.
------------------------------------------------------------------------
                 DEA Drug & Chemical Evaluation Section
------------------------------------------------------------------------
1308.21(a)--Exclusion of nonnarcotic     Drug Enforcement
 substance.                               Administration, Attn: Drug &
1308.23(b)--Exemption for chemical        Chemical Evaluation Section/
 preparations..                           ODE, 8701 Morrissette Drive,
                                          Springfield, VA 22152.
1308.24(d)--Exempt narcotic chemical
 preparations importer/exporter
 reporting.
1308.24(i)--Exempted chemical
 preparations listing.
1308.25(a)--Exclusion of veterinary
 anabolic steroid implant product
 application.
1308.26(a)--Excluded veterinary
 anabolic steroid implant products
 listing.
1308.31(a)--Exemption of a nonnarcotic
 prescription product application.
1308.32--Exempted prescription products
 listing.
1308.33(b)--Exemption of certain
 anabolic steroid products application.
1308.34--Exempted anabolic steroid
 products listing.
1310.13(b)--Exemption for chemical
 preparations.
1310.05(d)--Bulk manufacturer of listed
 chemicals reporting.
------------------------------------------------------------------------
                      UN Reporting & Quota Section
------------------------------------------------------------------------
1303.12(b)--Application for controlled   Drug Enforcement
 substances procurement quota (DEA Form   Administration, Attn: UN
 250) filing and request.                 Reporting & Quota Section/ODQ,
                                          8701 Morrissette Drive,
                                          Springfield, VA 22152.
1303.12(d)--Controlled substances quota
 adjustment request.

[[Page 63630]]

 
1303.22--Application for individual
 manufacturing quota (DEA Form 189)
 filing and request for schedule I or
 II controlled substances.
1304.31(a)--Manufacturers importing
 narcotic raw material report
 submission.
1304.32(a)--Manufacturers importing
 coca leaves report submission.
315.22--Application for individual
 manufacturing quota for ephedrine,
 pseudoephedrine, phenylpropanolamine
 (DEA Form 189) filing and request.
1315.32(e)--Application for procurement
 quota for ephedrine, pseudoephedrine,
 phenylpropanolamine (DEA Form 250)
 filing and request.
1315.32(g)--Procurement quota
 adjustment request for ephedrine,
 pseudoephedrine, phenylpropanolamine.
1315.34(d)--Application for import
 quota for ephedrine, pseudoephedrine,
 phenylpropanolamine (DEA Form 488)
 request and filing.
1315.36(b)--Request import quota
 increase for ephedrine,
 pseudoephedrine, or
 phenylpropanolamine
------------------------------------------------------------------------
                  Pharmaceutical Investigations Section
------------------------------------------------------------------------
1304.04(d)--ARCOS separate central       Drug Enforcement
 reporting identifier request.            Administration, Attn: ARCOS
1304.33(a)--Reports to ARCOS...........   Unit/ODPT, P.O. Box 2520,
                                          Springfield, VA 22152-2520 OR
                                          Drug Enforcement
                                          Administration, Attn: ARCOS
                                          Unit, 8701 Morrissette Drive,
                                          Springfield, VA 22152.
------------------------------------------------------------------------
                        DEA Registration Section
------------------------------------------------------------------------
1301.03--Procedures information request  Drug Enforcement
 (controlled substances registration).    Administration, Attn:
1301.13(e)(2)--Request DEA Forms 224,     Registration Section/ODR P.O.
 225, and 363..                           Box 2639, Springfield, VA
                                          22152-2639.
1301.14(a)--Controlled substances
 registration application submission.
1301.18(c)--Research project controlled
 substance increase request.
1301.51--Controlled substances
 registration modification request.
301.52(b)--Controlled substances
 registration transfer request.
1301.52(c)--Controlled substances
 registration discontinuance of
 business activities notification.
1309.03--List I chemicals registration
 procedures information request.
1309.32(c)--Request DEA Form 510.
1309.33(a)--List I chemicals
 registration application submission.
1309.61--List I chemicals registration
 modification request.
------------------------------------------------------------------------
                            DEA Hearing Clerk
------------------------------------------------------------------------
1301.43--Request for hearing or          Drug Enforcement
 appearance; waiver.                      Administration, Attn: Hearing
1303.34--Request for hearing or           Clerk/OALJ, 8701 Morrissette
 appearance; waiver..                     Drive, Springfield, VA 22152.
1308.44--Request for hearing or
 appearance; waiver.
1316.45--Hearings documentation filing.
1316.46(a)--Inspection of record.
1316.47(a)--Request for hearing........
1316.48--Notice of appearance.
------------------------------------------------------------------------
                   DEA Federal Register Representative
------------------------------------------------------------------------
1301.33(a)--Filing of written comments   https://www.regulations.gov/.
 regarding application for bulk           Drug Enforcement
 manufacture of Schedule I and II         Administration, Attn: Federal
 substances.**                            Register Representative/ODW,
1301.34(a)--Filing of written comments    8701 Morrissette Drive,
 regarding application for importation    Springfield, VA 22152.
 of Schedule I and II substances.**.
1303.11(c)--Filing of written comments
 regarding notice of an aggregate
 production quota.**
1303.13(c)--Filing of written comments
 regarding adjustments of aggregate
 production quotas.**
1303.13(c)--Filing of written comments
 regarding adjustments of aggregate
 production quotas.**
1308.43(g)--Filing of written comments
 regarding initiation of proceedings
 for rulemaking.**
------------------------------------------------------------------------
* Applications/filings/reports are required to be filed electronically
  in accordance with this chapter.
** Applications/filings/reports may be filed electronically in
  accordance with this chapter.



[[Page 63631]]

    Dated: September 1, 2016.
Chuck Rosenberg,
Acting Administrator.
[FR Doc. 2016-21589 Filed 9-14-16; 8:45 am]
 BILLING CODE 4410-09-P