Federal
Register Notices > Rules
- 2006 > Proposed Rule -
Reexportation of Controlled Substances
FR Doc E6-17275 [Federal Register: October 18, 2006 (Volume 71, Number
201)] [Proposed Rules] [Page 61436-61441] From the Federal Register Online via
GPO Access [wais.access.gpo.gov] [DOCID:fr18oc06-19]
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.
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: dea.diversion.policy@usdoj.gov.
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.
1 28 CFR 0.100(b).
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
to first country......................
|
400 |
15 minutes (0.25 hours)........
|
100 |
Certification of
reexportation from first country to
second country*......... |
1,200 |
15 minutes (0.25 hours)........
|
300 |
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
NOTICE: This is an
unofficial version. An official version of these publications may be obtained
directly from the Government Printing Office (GPO).
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