[Federal Register Volume 71, Number 201 (Wednesday, October 18, 2006)]
[Proposed Rules]
[Pages 61436-61441]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-17275]


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DEPARTMENT OF JUSTICE

Drug Enforcement Administration

21 CFR Part 1312

[Docket No. DEA-276P]
RIN 1117-AB00


Reexportation of Controlled Substances

AGENCY: Drug Enforcement Administration (DEA), Department of Justice.

ACTION: Notice of proposed rulemaking.

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SUMMARY: The Controlled Substances Export Reform Act of 2005 amended 
the Controlled Substances Import and Export Act to provide authority 
for the Drug Enforcement Administration (DEA) to authorize the export 
of controlled substances from the United States to another country for 
subsequent export from that country to a second country, if certain 
conditions and safeguards are satisfied. DEA is hereby proposing to 
amend its regulations to implement the new legislation.

DATES: Written comments must be postmarked, and electronic comments 
must be sent, on or before December 18, 2006.

ADDRESSES: Please submit comments, identified by ``Docket No. DEA-
276,'' by one of the following methods:
    1. Regular mail: Deputy Assistant Administrator, Office of 
Diversion Control, Drug Enforcement Administration, Washington, DC 
20537, Attention: DEA Federal Register Representative/ODL.
    2. Express mail: DEA Headquarters, Attention: DEA Federal Register 
Representative/ODL, 2401 Jefferson-Davis Highway, Alexandria, VA 22301.
    3. E-mail comments directly to agency: 
[email protected].
    4. Federal eRulemaking portal: http://www.regulations.gov. Follow 
the online instructions for submitting comments.
    Anyone planning to comment should be aware that all comments 
received before the close of the comment period will be made available 
in their entirety for public inspection, including any personal 
information submitted. For those submitting comments electronically, 
DEA will accept attachments only in the following

[[Page 61437]]

formats: Microsoft Word, WordPerfect, Adobe PDF, or Excel.

FOR FURTHER INFORMATION CONTACT: Mark W. Caverly, Chief, Liaison and 
Policy Section, Office of Diversion Control, Drug Enforcement 
Administration, Washington, DC 20537, Telephone (202) 307-7297.

SUPPLEMENTARY INFORMATION:

Background

    The Controlled Substances Export Reform Act of 2005 (Pub. L. 109-
57) was enacted on August 2, 2005. The Act amended the Controlled 
Substances Import and Export Act to provide authority for the Attorney 
General (and DEA, by delegation) \1\ to authorize the export of 
controlled substances from the United States to another country for 
subsequent export from that country to a second country, if certain 
conditions and safeguards are satisfied.
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    \1\ 28 CFR 0.100(b).
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    Previously under the Controlled Substances Import and Export Act 
(prior to the 2005 legislation), there were no circumstances in which 
it was permissible to export a controlled substance in Schedules I and 
II, or a narcotic controlled substance in Schedules III and IV, for the 
purpose of reexport to another country. Such controlled substances 
could lawfully be exported only to the immediate country where they 
would be consumed.
    With the passage of the Controlled Substances Export Reform Act of 
2005, Congress added a new provision, designated Section 1003(f) of the 
Controlled Substances Import and Export Act (21 U.S.C. 953(f)), which 
states:

    Notwithstanding [21 U.S.C. 953] subsections (a)(4) and (c)(3), 
the Attorney General may authorize any controlled substance that is 
in schedule I or II, or is a narcotic drug 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:
    (1) Both the country to which the controlled substance is 
exported from the United States (referred to in this subsection as 
the 'first country') and the country to which the controlled 
substance is exported from the first country (referred to in this 
subsection 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 
Attorney General 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 Attorney General by the person who will export the 
controlled substance from the United States that--
    (A) 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
    (B) 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) Within 30 days after the controlled substance is exported 
from the first country to the second country, the person who 
exported the controlled substance from the United States delivers to 
the Attorney General documentation certifying that such export from 
the first country has occurred.
    (7) A permit to export the controlled substance from the United 
States has been issued by the Attorney General.

    Note: The above text of the Act is published for the convenience 
of the reader, given that the Act sets forth what are essentially 
regulatory requirements that must be directly incorporated into this 
proposed rule. The official text is published at 21 U.S.C. 953(f).

DEA Proposed Implementation of the Controlled Substances Export Reform 
Act of 2005

    The rule being proposed here would amend DEA regulations to 
implement this new legislation. Most of the amendments to the 
regulations being proposed here either reiterate the new statutory 
provisions added by the 2005 Act or specify the procedural details for 
complying with the new statutory provisions. In three respects, 
however, the proposed rule contains substantive requirements not 
contained in the statute. The first additional proposed requirement is 
that the reexporter notify DEA when the shipment leaves the United 
States. The second additional proposed requirement is that the reexport 
from the first country to the second country take place within 90 days 
after the shipment leaves the United States. The third additional 
proposed requirement is that bulk materials undergo further 
manufacturing in the first country prior to being shipped to the second 
country. This is the same requirement contained in existing DEA 
regulations for reexports of nonnarcotic controlled substances in 
Schedules III and IV and Schedule V controlled substances (21 CFR 
1312.27(b)(5)).
    It is proposed that these three additional requirements would 
entail minimal regulatory burden yet allow the agency to carry out the 
2005 Act more effectively. Under the 2005 Act (subsection (6)), 
Congress mandated that the reexporter notify DEA within 30 days after 
the controlled substance is shipped from the first country to the 
second country. It can be inferred that one purpose of this provision 
is to provide a means for DEA to maintain an awareness of the status of 
shipments leaving the United States for reexport and thereby enhance 
the agency's ability to monitor and prevent diversion of such 
shipments. The three additional proposed requirements listed above 
further this same goal by eliminating the possibility that DEA would be 
unable to ascertain the status of an approved reexport for an 
indefinite period of time. Without the requirements being proposed 
here, a scenario could arise in which DEA has issued a permit 
authorizing a reexport, yet be without sufficient documentation to 
determine whether the shipment (i) has remained for many months in the 
first country without being reexported, (ii) has been improperly 
reexported to a different second country than that indicated on the 
reexport application, or (iii) was properly reexported to the second 
country but the reexporter failed to notify DEA within 30 days as 
required by the statute. The proposed additional notification 
requirement and the 90-day time limit for reexports is intended to 
minimize the likelihood of such uncertainties regarding the status of 
reexport shipments and thereby minimize the likelihood of diversion.
    Requiring that reexports be completed within a finite time frame is 
also consistent with the historical approach in the DEA regulations 
that export permits be of a finite duration. See 21 CFR 1312.25 
(setting forth expiration dates for export permits and providing 
maximum duration of six months).
    Finally, it is anticipated that it will not be unduly burdensome 
for reexporters to notify DEA within 30 days after the shipment has 
left the United States or to complete the reexport within 90 days 
thereafter. DEA notes that the statute requires the reexporter (as a 
condition of obtaining an export permit from DEA) to specify both the 
first and the second countries, and to provide substantial evidence 
that, with respect to the second country, 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.

[[Page 61438]]

Further, the statute requires the exporter to provide substantial 
evidence that the controlled substance is to be applied exclusively to 
medical, scientific, or other legitimate uses within the second 
country. Therefore, DEA anticipates that reexporters will, themselves, 
seek to complete the reexport well within 90 days of arriving within 
the first country. DEA welcomes comments on these and any other 
relevant considerations.

Treaty Considerations

    The first two subsections of the 2005 Act pertain to the Single 
Convention on Narcotic Drugs, 1961 (Single Convention), and the 
Convention on Psychotropic Substances, 1971 (Psychotropic Convention). 
Under these provisions, a reexport may take place only if both the 
first and second country are parties to both treaties and only if the 
Attorney General (DEA) determines that both the first country and the 
second country maintain an adequate system of controls in conformity 
with the treaties.
    Thus, Congress expressly intended that reexports take place in 
accordance with the treaties. The control measures imposed under the 
2005 Act, along with the regulations being proposed here, are intended 
to work in tandem with the international control regimes under the 
treaties. The ultimate goal of the 2005 Act and this proposed rule is 
to permit exportation of controlled substances in Schedules I and II 
and narcotic controlled substances in Schedules III and IV from the 
United States to a first country for subsequent exportation to one or 
more second countries while preventing international diversion 
resulting from reexports. Whenever considering safeguards against 
diversion of international shipments, one must bear in mind the 
backdrop of the treaties. Toward this end, the following treaty 
principles are noted.
    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. For example, the INCB may 
notify parties if the quantity of drugs exported to a particular 
country exceeded the estimates for that country. Parties that receive 
such notification from the INCB are prohibited from authorizing further 
exports of the drug concerned to that country.
    The United States has always viewed as critical its obligation to 
work with the INCB closely to monitor imports and exports, and to take 
additional appropriate measures to safeguard against diversion. 
Therefore, based on the principles of the Single Convention and 
Psychotropic Convention pertaining to international drug control, and 
based on the requirements of the Controlled Substances Export Reform 
Act regarding the reporting of reexportations, DEA is proposing the 
additional requirements discussed above to ensure that DEA has the 
information necessary to determine whether controlled substances 
shipments intended for reexportation are occurring as initially 
reported to DEA or being diverted to illicit purposes.

Issuance of Permits

    Under the 2005 Act, before a controlled substance can be exported 
for subsequent reexport, the exporter must obtain from DEA a permit 
that authorizes the export for this purpose. Consistent with the 2005 
Act, DEA may only issue such permit if each of the conditions specified 
in the Act is met. Each of these conditions is restated in the proposed 
rule. Although most of these conditions are self-explanatory, some 
additional explanation is warranted.
    First, as the proposed rule indicates, DEA will be issuing a new 
application form, DEA Form 161-r, for a permit to export controlled 
substances for subsequent reexport in accordance with the 2005 Act. The 
proposed rule also indicates what will constitute ``substantial 
evidence'' for purposes of subsection (4) of the 2005 Act. 
Specifically, if on the completed DEA 161-r, the applicant has 
identified an appropriately licensed or permitted consignee in the 
second country and certified that the second country is a party to the 
Conventions and maintains a system of controls of imports consistent 
with the requirements of the treaties, and so affirmed in the affidavit 
section of the application, DEA will consider this substantial evidence 
that a permit or license to import the controlled substance will be 
issued by the second country.

Reexportation to More Than One Second Country

    DEA believes it is consistent with the text, structure, and purpose 
of the 2005 Act to allow a shipment of controlled substances to be 
exported from the United States to a ``first country'' for reexport to 
more than one ``second country,'' (but not further export from any 
second country to a third country) provided the exporter notifies DEA 
of such intent in the application for export permit, and provided 
further that the statute is fully complied with in all other respects. 
The proposed rule expressly provides for reexport to more than one 
second country, and the new Form 161-r will be structured accordingly. 
For example, DEA must be able to determine, based on information 
contained in the permit application (DEA Form 161-r), that each named 
second country is a party to the Single Convention and Psychotropic 
Convention and that each such country has instituted and maintains, in 
conformity with such treaties, a system of controls that DEA deems 
adequate.

Refused Shipments

    Under current DEA regulations, 21 CFR 1312.27(b)(5), it is 
permissible under the conditions specified therein to reexport non-
narcotic controlled substances in Schedules III and IV, and controlled 
substances in Schedule V. Subsection 1312.27(b)(5)(iv) of this existing 
regulation addresses the situation where a shipment has been exported 
from the United States but is refused by the consignee in the country 
of destination (the second country), or is otherwise unacceptable or 
undeliverable. The rule being proposed here would apply the same type 
of procedures set forth in subsection 1312.27(b)(5)(iv) to reexports 
under the 2005 Act, whereby the exporter may seek permission from DEA, 
in appropriate circumstances, to return the shipment to the registered 
exporter in the United States.

Regulatory Certifications

Regulatory Flexibility Act

    The Deputy Assistant Administrator hereby certifies that this 
rulemaking has been drafted in accordance with the Regulatory 
Flexibility Act (5 U.S.C. 605(b)), has reviewed this regulation, and by 
approving it certifies that this regulation will not have a significant 
economic impact on a substantial

[[Page 61439]]

number of small entities. This rulemaking permits Schedule I and II 
controlled substances, and narcotic controlled substances in Schedules 
III and IV, to be exported from the United States to the first country 
for subsequent reexport to second countries for consumption. Previously 
such reexportation was not permitted within DEA law and regulations.

Executive Order 12866

    The Deputy Assistant Administrator further certifies that this 
rulemaking has been drafted in accordance with the principles in 
Executive Order 12866 Sec.  1(b). DEA has determined that this is a 
significant regulatory action. Therefore, this action has been reviewed 
by the Office of Management and Budget.

Executive Order 12988

    This regulation meets the applicable standards set forth in 
Sec. Sec.  3(a) and 3(b)(2) of Executive Order 12988 Civil Justice 
Reform.

Executive Order 13132

    This rulemaking does not preempt or modify any provision of state 
law; nor does it impose enforcement responsibilities on any state; nor 
does it diminish the power of any state to enforce its own laws. 
Accordingly, this rulemaking does not have federalism implications 
warranting the application of Executive Order 13132.

Unfunded Mandates Reform Act of 1995

    This rule will not result in the expenditure by State, local, and 
tribal governments, in the aggregate, or by the private sector, of 
$118,000,000 or more in any one year, and will not significantly or 
uniquely affect small governments. Therefore, no actions were deemed 
necessary under the provisions of the Unfunded Mandates Reform Act of 
1995.

Paperwork Reduction Act of 1995

    The Department of Justice, Drug Enforcement Administration, is 
revising the information collection entitled ``Application for Permit 
to Export Controlled Substances'', by adding a new DEA Form 161-r to be 
used by persons applying for a permit to reexport controlled substances 
in Schedules I and II, and narcotic controlled substances in Schedules 
III and IV. DEA has submitted the new DEA Form 161-r and the 
information collection request to the Office of Management and Budget 
for review and clearance in accordance with review procedures of the 
Paperwork Reduction Act of 1995. The proposed information collection is 
published to obtain comments from the public and affected agencies.
    All comments and suggestions, or questions regarding additional 
information, to include obtaining a copy of the proposed information 
collection instrument with instructions, should be directed to Mark W. 
Caverly, Chief, Liaison and Policy Section, Office of Diversion 
Control, Drug Enforcement Administration, Washington, DC 20537, 
Telephone: (202) 307-7297. Written comments and suggestions from the 
public and affected agencies concerning the proposed collection of 
information are encouraged. Comments should address one or more of the 
following four points:
    (1) Evaluate whether the proposed collection of information is 
necessary for the proper performance of the functions of the agency, 
including whether the information will have practical utility;
    (2) Evaluate the accuracy of the agency's estimate of the burden of 
the proposed collection of information, including the validity of the 
methodology and assumptions used;
    (3) Enhance the quality, utility, and clarity of the information to 
be collected; and
    (4) Minimize the burden of the collection of information on those 
who are to respond, including through the use of appropriate automated, 
electronic, mechanical, or other technological collection techniques or 
other forms of information technology, e.g., permitting electronic 
submission of responses.
    Overview of this information collection:
    (1) Type of Information Collection: Revision of an existing 
collection.
    (2) Title of the Form/Collection: Application for Permit to Export 
Controlled Substances.
    (3) Agency form number, if any, and the applicable component of the 
Department of Justice sponsoring the collection:
    Form Number: DEA Form 161, Application for Permit to Export 
Controlled Substances; DEA Form 161-r, Application for Permit to Export 
Controlled Substances for Subsequent Reexport.
    Office of Diversion Control, Drug Enforcement Administration, U.S. 
Department of Justice.
    (4) Affected public who will be asked or required to respond, as 
well as a brief abstract:
    Primary: Business or other for-profit.
    Other: None.
    Abstract: Title 21 CFR 1312.21 and 1312.22 require persons who 
export controlled substances in Schedules I and II and who reexport 
controlled substances in Schedules I and II and narcotic controlled 
substances in Schedules III and IV to obtain a permit from DEA. 
Information is used to issue export permits, exercise control over 
exportation of controlled substances, and compile data for submission 
to the United Nations to comply with treaty requirements.
    (5) An estimate of the total number of respondents and the amount 
of time estimated for an average respondent to respond: It is estimated 
that 90 respondents will respond, with submissions as follows:

----------------------------------------------------------------------------------------------------------------
                                                   Number of
                                                   responses        Average time per response      Total (hours)
----------------------------------------------------------------------------------------------------------------
DEA Form 161 (exportation only)...............           2,200  30 minutes (0.5 hours)..........           1,100
DEA Form 161-r (reexportation)................             400  45 minutes (0.75 hours).........             300
Certification of exportation from United                   400   15 minutes (0.25 hours)........             100
 States to first country.
Certification of reexportation from first                1,200  15 minutes (0.25 hours).........             300
 country to second country*.
                                               ----------------                                  ---------------
    Total.....................................           4,200  ................................          1,800
----------------------------------------------------------------------------------------------------------------
*Assumes three separate reexports to second countries.


[[Page 61440]]

    (6) An estimate of the total public burden (in hours) associated 
with the collection: The total public burden (in hours) for this 
collection is estimated to be 1,800 hours.

Small Business Regulatory Enforcement Fairness Act of 1996

    This rule is not a major rule as defined by Section 804 of the 
Small Business Regulatory Enforcement Fairness Act of 1996. This rule 
will not result in an annual effect on the economy of $100,000,000 or 
more; a major increase in costs or prices; or significant adverse 
effects on competition, employment, investment, productivity, 
innovation, or on the ability of United States-based companies to 
compete with foreign-based companies in domestic and export markets.

List of Subjects in 21 CFR Part 1312

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

    For the reasons set out above, 21 CFR part 1312 is proposed to be 
amended as follows:

PART 1312--IMPORTATION AND EXPORTATION OF CONTROLLED SUBSTANCES 
[AMENDED]

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

    Authority: 21 U.S.C. 952, 953, 954, 957, 958.

    2. Sec.  1312.22 is proposed to be amended by revising paragraph 
(a) and adding paragraphs (c) through (e) to read as follows:


Sec.  1312.22  Application for export permit.

    (a) An application for a permit to export controlled substances 
shall be made on DEA Form 161, and an application for a permit to 
reexport controlled substances shall be made on DEA Form 161-r. Forms 
may be obtained from, and shall be filed with, the Drug Enforcement 
Administration, Import/Export Unit, Washington, DC 20537. Each 
application shall show the exporter's name, address, and registration 
number; a detailed description of each controlled substance desired to 
be exported 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 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 shall include the 
name, address, and business of the consignee, foreign port of entry, 
the port of exportation, the approximate date of exportation, the name 
of the exporting carrier or vessel (if known, or if unknown it should 
be stated whether shipment will be made by express, freight, or 
otherwise, exports of controlled substances by mail being prohibited), 
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. The application shall also 
contain an affidavit that the packages are labeled in conformance with 
obligations of the United States under international treaties, 
conventions, or protocols in effect on May 1, 1971. The affidavit shall 
further state that to the best of 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 (c) and (d) 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. The application shall be signed and dated by the exporter 
and shall contain the address from which the substances will be shipped 
for exportation.
* * * * *
    (c) Notwithstanding paragraphs (a) and (b) of this section, the 
Administration may authorize any controlled substance listed in 
Schedule I or II, or any narcotic drug listed in Schedule III or IV, to 
be exported from the United States to a country for subsequent export 
from that country to another country, if each of the following 
conditions is met, in accordance with Sec.  1003(f) of the Controlled 
Substances Import and Export 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 person who exported the controlled substance from the 
United States has complied with paragraph (d) of this section and a 
permit to export the controlled substance from the United States has 
been issued by the Administration; and
    (7) Within 30 days after the controlled substance is exported from 
the first country to the second country, the person who exported the 
controlled substance from the United States must deliver to the 
Administration documentation certifying that such export from the first 
country has occurred. If the permit issued by the Administration 
authorized the reexport of a controlled substance from the first 
country to more than one second country, notification of each 
individual reexport shall be provided. This documentation shall be 
submitted on company letterhead, signed by the responsible company 
official, and shall include the following information:
    (i) Name of second country;
    (ii) Actual quantity shipped;
    (iii) Actual date shipped; and
    (iv) DEA export permit number for the original export.
    (d) Where a person is seeking to export a controlled substance for

[[Page 61441]]

reexport in accordance with paragraph (c) of this section, the 
following requirements shall apply in addition to (and not in lieu of) 
the requirements of paragraphs (a) and (b) 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 country of ultimate consumption.
    (2) Finished dosage units, if reexported, must be in a commercial 
package, properly sealed and labeled for legitimate medical use in the 
country of destination (the second country);
    (3) Any proposed reexportation must be made known to the 
Administration at the time the initial DEA Form 161-r 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 country to where the substances will be reexported.
    (4) The application (DEA Form 161-r) must also contain an affidavit 
that the consignee in the country of ultimate destination (the second 
country) is authorized under the laws and regulations of the country of 
ultimate destination to receive the controlled substances. The 
affidavit must also contain the following statement, in addition to the 
statements required under paragraph (a) 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;
    (ii) That the controlled substances are to be applied exclusively 
to medical or scientific uses within the country to which reexported 
(the second country);
    (iii) That the controlled substances will not be further reexported 
from the second country, and
    (iv) That there is an actual need for the controlled substances for 
medical or scientific uses within the second country.
    (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 shall so indicate on the DEA Form 161-r, providing all the 
information required in this section for each second country.
    (6) Within 30 days after the controlled substance is exported from 
the United States, the person who exported the controlled substance 
shall deliver to the Administration documentation on the DEA Form 161-r 
initially completed for the transaction certifying that such export 
occurred. This documentation shall be signed by the responsible company 
official and shall include the following information:
    (i) Actual quantity shipped;
    (ii) Actual date shipped; and
    (iii) DEA export permit number.
    (7) The controlled substance will be reexported from the first 
country to the second country (or second countries) no later than 90 
days after the controlled substance was exported from the United 
States.
    (8) Shipments that have been exported from the United States and 
are refused by the consignee in the country of destination (the second 
country), 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 shall file 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, Application for Import Permit, with the Drug Enforcement 
Administration, Import/Export Unit, Washington, DC 20537. 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 documentation, the 
Administration will issue an import permit for the return of these 
drugs, and the exporter can then obtain an export permit from the 
country of original importation. The substance may be returned to the 
United States only after affirmative authorization is issued in writing 
by the Administration.
    (e) In considering whether to grant an application for a permit 
under paragraphs (c) and (d) 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.
    3. Section 1312.23 is proposed to be amended by revising paragraphs 
(a) and (f) to read as follows:


Sec.  1312.23  Issuance of export permit.

    (a) The Administration may authorize exportation of any controlled 
substance listed in Schedule I or II or any narcotic controlled 
substance listed in Schedule III or IV if he finds that such 
exportation is permitted by subsections 1003(a), (b), (c), (d), or (f) 
of the Act (21 U.S.C. Sec.  953(a), (b), (c), (d), or (f).
* * * * *
    (f) No export permit shall be issued for the exportation, or 
reexportation, of any controlled substance to any country when the 
Administration has information to show that the estimates or 
assessments submitted with respect to that country for the current 
period, under the Single Convention on Narcotic Drugs, 1961, or the 
Convention on Psychotropic Substances, 1971, have been, or, considering 
the quantity proposed to be imported, will be exceeded. If it shall 
appear through subsequent advice received from the International 
Narcotics Control Board of the United Nations that the estimates or 
assessments of the country of destination have been adjusted to permit 
further importation of the controlled substance, an export permit may 
then be issued if otherwise permissible.

    Dated: October 10, 2006.
Joseph T. Rannazzisi,
Deputy Assistant Administrator, Office of Diversion Control.
 [FR Doc. E6-17275 Filed 10-17-06; 8:45 am]
BILLING CODE 4410-09-P