[Federal Register Volume 79, Number 66 (Monday, April 7, 2014)]
[Rules and Regulations]
[Pages 18990-18995]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-07572]


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DEPARTMENT OF THE TREASURY

Office of Foreign Assets Control

31 CFR Part 560


Iranian Transactions and Sanctions Regulations

AGENCY: Office of Foreign Assets Control, Treasury.

ACTION: Final rule.

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SUMMARY: The Department of the Treasury's Office of Foreign Assets 
Control (``OFAC'') is adopting a final rule amending the Iranian 
Transactions and Sanctions Regulations (``ITSR'') by expanding an 
existing general license that authorizes the exportation or 
reexportation of food to individuals and entities in Iran to include 
the broader category of agricultural commodities. The rule also 
clarifies and adds certain definitions in OFAC regulations. Finally, 
the rule adds a new general license that authorizes the exportation or 
reexportation of certain replacement parts for certain medical devices.

DATES: Effective: April 7, 2014.

FOR FURTHER INFORMATION CONTACT: Assistant Director for Licensing, 
tel.: 202/622-2480, Assistant Director for Policy, tel.: 202/622-2746, 
Assistant Director for Regulatory Affairs, tel.: 202/622-4855, 
Assistant Director for Sanctions Compliance and Evaluation, tel.: 202/
622-2490, Office of Foreign Assets Control, or Chief Counsel (Foreign 
Assets Control), tel.: 202/622-2410, Office of the General Counsel, 
Department of the Treasury (not toll free numbers).

SUPPLEMENTARY INFORMATION: OFAC is adopting a final rule amending the 
ITSR by expanding an existing general license that authorizes the 
exportation or reexportation of food to individuals and entities in 
Iran to include the broader category of agricultural commodities. 
Exports of certain specified items, as well as exports to certain 
persons, are excluded from the general license.
    Additionally, OFAC is clarifying, for purposes of the general 
licenses in ITSR Sec.  560.530, that the definitions of the terms 
agricultural commodities, medicine, and medical device include, in the 
case of items subject to the Export Administration Regulations, 15 CFR 
Part 730 et seq. (``EAR''), items that are designated as EAR99 and, in 
the case of items that are not subject to the EAR, items that would be 
designated as EAR99 if they were located in the United States.
    Furthermore, this rule adds a definition of ``covered person,'' 
which, with respect to the exportation or reexportation of items 
subject to the EAR, is a U.S. person or a non-U.S. person, and for 
purposes of items not subject to the EAR, is a U.S. person, wherever 
located, or an entity owned or controlled by a U.S. person and 
established or maintained outside the United States (a ``U.S.-owned or 
-controlled foreign entity''). This amendment clarifies that, for 
purposes of the exportation or reexportation of items that are not 
subject to the EAR, and consistent with 31 CFR 560.556, the general 
licenses set forth in Sec.  560.530 apply to any U.S. person, wherever 
located, or any U.S.-owned or -controlled foreign entity.
    Finally, OFAC is adding a new general license that authorizes the 
exportation or reexportation of replacement parts for certain medical 
devices to individuals and entities in Iran provided that the 
replacement parts are designated under the EAR as EAR99, or would be 
designated as EAR99 if they were located in the United States, and 
limited to a one-for-one export or reexport basis. This rule also 
updates the definition of ``basic medical supplies'' to exclude the 
word ``basic'' and make related conforming changes. Accordingly, the 
``List of Basic Medical

[[Page 18991]]

Supplies'' published on the OFAC Web site and in the Federal Register 
will now be called the ``List of Medical Supplies.''

Electronic and Facsimile Availability

    This document and additional information concerning OFAC are 
available from OFAC's Web site (www.treasury.gov/ofac). Certain general 
information pertaining to OFAC's sanctions programs is also available 
via facsimile through a 24-hour fax-on-demand service, tel.: 202/622-
0077.

Background

    OFAC is adopting a final rule amending the ITSR, 31 CFR Part 560, 
by expanding the general license set forth in Sec.  560.530(a)(2) that 
authorizes the exportation or reexportation of food to Iran to include 
the broader category of agricultural commodities. Exports of certain 
specified items, as well as exports to certain persons, are excluded 
from the general license. Additionally, OFAC is clarifying, for 
purposes of the general licenses in ITSR Sec.  560.530, the definitions 
of the terms agricultural commodities, medicine, and medical device, as 
set forth in more detail below. Finally, OFAC is adding a new general 
license that authorizes the exportation or reexportation of replacement 
parts for certain medical devices to individuals and entities in Iran 
provided that the replacement parts are designated as EAR99, or would 
be designated as EAR99 if they were located in the United States, and 
further provided that the replacement parts are limited to a one-for-
one export or reexport basis. Today's amendments also update the 
definition of ``basic medical supplies'' to exclude the word ``basic'' 
and make related conforming changes. Accordingly, the ``List of Basic 
Medical Supplies'' published on the OFAC Web site and in the Federal 
Register will now be called the ``List of Medical Supplies.''
    The Trade Sanctions Reform and Export Enhancement Act of 2000, as 
amended (22 U.S.C. 7201 et seq.) (``TSRA''), provides that, with 
certain exceptions, the President may not impose a unilateral 
agricultural sanction or unilateral medical sanction against a foreign 
country or foreign entity unless, at least 60 days before imposing such 
a sanction, the President submits a report to Congress describing the 
proposed sanction and the reasons for it and Congress enacts a joint 
resolution approving the report. See 22 U.S.C. 7202. Section 906 of 
TSRA, however, requires in pertinent part that the export of 
agricultural commodities, medicine, or medical devices to the 
government of a country that has been determined by the Secretary of 
State, pursuant to, inter alia, section 6(j) of the Export 
Administration Act of 1979 (50 U.S.C. App. 2405(j)), to have repeatedly 
provided support for acts of international terrorism,\1\ or to any 
entity in such a country, shall be made pursuant to one-year licenses 
issued by the United States Government, except that the requirements of 
such one-year licenses shall be no more restrictive than general 
licenses administered by the Department of the Treasury. See 22 U.S.C. 
7205(a)(1). Section 906 also specifies that procedures be in place to 
deny licenses for exports of agricultural commodities, medicine, or 
medical devices to any entity within such country promoting 
international terrorism.
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    \1\ The Secretary of State has made such a determination with 
respect to Iran.
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    Moreover, as provided in section 221 of the USA PATRIOT Act (Pub. 
L. 107-56) (codified at 22 U.S.C. 7210), nothing in TSRA shall limit 
the application or scope of any law, including any Executive order or 
regulation promulgated pursuant to such law, establishing criminal or 
civil penalties for the unlawful export of any agricultural commodity, 
medicine, or medical device to a Foreign Terrorist Organization; a 
foreign organization, group, or person designated pursuant to Executive 
Orders 12947 or 13224 (sanctions on terrorists and certain supporters 
of terrorism); weapons of mass destruction or missile proliferators; or 
designated narcotics trafficking entities. In addition, TSRA itself 
provides in section 904(2) that the restrictions on the imposition of 
unilateral agricultural sanctions or unilateral medical sanctions shall 
not affect any authority or requirement to impose a sanction to the 
extent such sanction applies to any agricultural commodity, medicine, 
or medical device that is (A) controlled on the United States Munitions 
List (the ``USML''), (B) controlled on any control list established 
under the Export Administration Act of 1979 or any successor statute, 
or (C) used to facilitate the design, development, or production of 
chemical or biological weapons, missiles, or weapons of mass 
destruction. See 22 U.S.C. 7203(2).
    On October 12, 2011, OFAC adopted a final rule issuing a general 
license set forth in the ITSR Sec.  560.530(a)(2) authorizing the 
exportation or reexportation of food (as defined in the general 
license), including bulk agricultural commodities listed in appendix B 
to the ITSR, to the Government of Iran, to any individual or entity in 
Iran, or to persons in third countries purchasing specifically for 
resale to any of the foregoing, and the conduct of related transactions 
(see 76 FR 63191). Separately, OFAC has routinely issued specific 
licenses authorizing the exportation or reexportation of agricultural 
commodities (other than food items as previously defined in ITSR 
section 560.530(a)(2)) to the Government of Iran, individuals or 
entities in Iran, or persons in third countries purchasing specifically 
for resale to any of the foregoing, and the conduct of related 
transactions. In addition, OFAC has continued to review its TSRA 
licensing procedures, particularly the procedures for licensing exports 
of agricultural commodities.
    As a result of this review, OFAC today is further expanding the 
general license set forth at ITSR Sec.  560.530(a)(2), which, prior to 
today's amendment, authorized the exportation and reexportation of food 
(including bulk agricultural commodities listed on appendix B to the 
ITSR), to authorize the exportation or reexportation of the broader 
category of agricultural commodities, with certain specified 
exceptions, to the Government of Iran, to individuals or entities in 
Iran, or to persons in third countries purchasing specifically for 
resale to any of the foregoing, and the conduct of related 
transactions. Activities authorized pursuant to ITSR Sec.  
560.530(a)(2), as amended today, are subject to the proviso that, 
unless otherwise authorized by specific license, payment terms and 
financing for sales pursuant to the general license are limited to, and 
consistent with, those authorized by ITSR Sec.  560.532, and the 
further proviso that all such exports or reexports must be shipped 
within the 12-month period beginning on the date of the signing of the 
contract for export or reexport. All food items authorized by the 
general license prior to today's amendment continue to be authorized 
under the general license, as amended. Each year, OFAC will determine 
whether to revoke this general license. Unless revoked, this general 
license will remain in effect.
    OFAC has determined that the exportation or reexportation of a 
small number of specified agricultural commodities to the Government of 
Iran, to any individual or entity in Iran, or to persons in third 
countries purchasing specifically for resale to any of the foregoing, 
as well as the exportation or reexportation of agricultural commodities 
to military or law enforcement purchasers or importers, continue to 
require the level of review

[[Page 18992]]

afforded by specific licensing. As a result, the general license set 
forth at ITSR Sec.  560.530(a)(2), as amended today, does not authorize 
the exportation or reexportation to Iran of castor beans, castor bean 
seeds, certified pathogen-free eggs (unfertilized or fertilized), dried 
egg albumin, live animals (excluding live cattle), embryos (excluding 
cattle embryos), Rosary/Jequirity peas, non-food-grade gelatin powder, 
peptones and their derivatives, super absorbent polymers, western red 
cedar, or all fertilizers. (See ITSR Sec.  560.530(a)(2)(ii) for the 
exclusion of these items.) Similarly, the general license, as amended 
today, does not authorize the exportation or reexportation of 
agricultural commodities to military or law enforcement purchasers or 
importers. (See ITSR Sec.  560.530(a)(2)(iii) for the exclusion of 
these persons.) The general license, as amended today, also does not 
authorize any transaction or dealing with a person whose property and 
interests in property are blocked under, or who is designated or 
otherwise subject to any sanction under, inter alia, the terrorism, 
proliferation of weapons of mass destruction, or narcotics trafficking 
programs administered by OFAC. (See ITSR Sec.  560.530(d)(5).)
    Additionally, OFAC is clarifying, for purposes of the general 
licenses in ITSR Sec.  560.530, that the definitions of the terms 
agricultural commodities, medicine, and medical device include, in the 
case of items subject to the Export Administration Regulations, 15 CFR 
Part 730 et seq. (``EAR''), items that are designated as EAR99 and, in 
the case of items that are not subject to the EAR, items that would be 
designated as EAR99 if they were located in the United States. (See 
ITSR Sec.  560.530(e).) For example, a company located in the United 
States may be authorized under the general license set forth at Sec.  
560.530(a)(2) to arrange for the export from a third country to Iran of 
agricultural commodities produced in the third country if those 
commodities would be designated as EAR99 if they were located in the 
United States.
    Furthermore, this rule adds a definition of covered person, which, 
with respect to the exportation or reexportation of items subject to 
the EAR, is a U.S. person or a non-U.S. person, and for purposes of 
items not subject to the EAR, a U.S. person, wherever located, or an 
entity owned or controlled by a U.S. person and established or 
maintained outside the United States (a ``U.S.-owned or -controlled 
foreign entity''). This amendment clarifies that, for purposes of the 
exportation or reexportation of items that are not subject to the EAR, 
and consistent with 31 CFR 560.556, the general licenses set forth in 
Sec.  560.530 apply to any U.S. person, wherever located, or any U.S.-
owned or -controlled foreign entity. For example, a U.S.-owned or -
controlled foreign entity may be authorized under the general license 
set forth at Sec.  560.530(a)(2) to arrange for the reexport to Iran of 
EAR99 medicines, as well as the export to Iran of medicines not subject 
to the EAR (e.g., medicines produced outside the U.S. by a non-U.S. 
person with no controlled U.S. content) that would be designated as 
EAR99 if they were located in the United States.
    The general licenses set forth at ITSR Sec.  560.530(a)(2) through 
(4) do not authorize, and specific licenses are therefore still 
required for, the exportation or reexportation of the following to the 
Government of Iran (wherever located), to any individual or entity in 
Iran, or to persons in third countries purchasing specifically for 
resale to any of the foregoing, and for the conduct of related 
transactions:

--the excluded agricultural commodities specified in ITSR Sec.  
560.530(a)(2)(ii);
--the excluded medicines specified in ITSR Sec.  560.530(a)(3)(iii);
--medical devices other than medical supplies as defined in Sec.  
560.530(a)(3)(ii); or
--agricultural commodities, medicine, or medical supplies to military 
or law enforcement purchasers or importers.

    In the course of continually reviewing its TSRA licensing 
procedures, OFAC also adopted a final rule on October 22, 2012, issuing 
a new general license set forth at ITSR Sec.  560.530(a)(3) authorizing 
the exportation or reexportation to Iran of medicine and basic medical 
supplies (as defined in the general license and included in a List of 
Basic Medical Supplies posted to OFAC's Web site) (see 77 FR 64664). 
The definition of basic medical supplies as originally published on 
October 22, 2012, specifically excluded replacement parts. On July 25, 
2013, OFAC updated the List of Basic Medical Supplies to include 
additional items. This update added to the list, among other items, 
certain EAR99-designated accessories, components, and optional 
equipment for use with medical devices included elsewhere on the list, 
which are distinct from replacement parts.
    OFAC has now determined, however, that the export or reexport of 
replacement parts for certain medical devices should be authorized, 
provided that the replacement parts are designated as EAR99 or, in the 
case of replacement parts that are not subject to the EAR, would be 
designated as EAR99 if they were located in the United States, and 
further provided that the replacement parts are limited to a one-for-
one basis (i.e., only one replacement part can be exported or 
reexported to replace a broken or non-operational component). 
Accordingly, OFAC today is issuing a new general license set forth at 
ITSR Sec.  560.530(a)(4) authorizing the exportation or reexportation 
of replacement parts that are designated as EAR99, or that would be 
designated as EAR99 if they were located in the United States, for 
medical devices on a one-for-one basis and with certain exceptions, to 
the Government of Iran, to individuals or entities in Iran, or to 
persons in third countries purchasing specifically for resale to any of 
the foregoing, and the conduct of related transactions. Each year, OFAC 
will determine whether to revoke this general license. Unless revoked, 
this general license will remain in effect.

Public Participation

    Because the amendment of 31 CFR Part 560 involves a foreign affairs 
function, the provisions of Executive Order 12866 of September 30, 
1993, and the Administrative Procedure Act (5 U.S.C. 553), requiring 
notice of proposed rulemaking, opportunity for public participation, 
and delay in effective date, are inapplicable. Because no notice of 
proposed rulemaking is required for this rule, the Regulatory 
Flexibility Act (5 U.S.C. 601-612) does not apply.

Paperwork Reduction Act

    The collections of information related to the Regulations are 
contained in 31 CFR Part 501 (the ``Reporting, Procedures and Penalties 
Regulations''). Pursuant to the Paperwork Reduction Act of 1995 (44 
U.S.C. 3507), those collections of information have been approved by 
the Office of Management and Budget under control number 1505-0164. An 
agency may not conduct or sponsor, and a person is not required to 
respond to, a collection of information unless the collection of 
information displays a valid control number.

List of Subjects in 31 CFR Part 560

    Administrative practice and procedure, Agricultural commodities, 
Banks, Banking, Blocking of assets, Drugs, Exports, Food, Foreign 
trade, Humanitarian aid, Investments, Iran, Loans, Medical devices, 
Medicine, Penalties, Services, Specially designated nationals, 
Terrorism, Transportation, Weapons of mass destruction.


[[Page 18993]]


    For the reasons set forth in the preamble, the Department of the 
Treasury's Office of Foreign Assets Control amends 31 CFR Part 560 as 
follows:

PART 560--IRANIAN TRANSACTIONS AND SANCTIONS REGULATIONS

0
1. The authority citation for part 560 is revised to read as follows:

    Authority:  3 U.S.C. 301; 18 U.S.C. 2339B, 2332d; 22 U.S.C. 
2349aa-9; 22 U.S.C. 7201-7211; 31 U.S.C. 321(b); 50 U.S.C. 1601-
1651, 1701-1706; Pub. L. 101-410, 104 Stat. 890 (28 U.S.C. 2461 
note); Pub. L. 110-96, 121 Stat. 1011 (50 U.S.C. 1705 note); Pub. L. 
111-195, 124 Stat. 1312 (22 U.S.C. 8501-8551); Pub. L. 112-81, 125 
Stat. 1298 (22 U.S.C. 8513a); Pub. L. 112-158, 126 Stat. 1214 (22 
U.S.C. 8701-8795); E.O. 12613, 52 FR 41940, 3 CFR, 1987 Comp., p. 
256; E.O. 12957, 60 FR 14615, 3 CFR, 1995 Comp., p. 332; E.O. 12959, 
60 FR 24757, 3 CFR, 1995 Comp., p. 356; E.O. 13059, 62 FR 44531, 3 
CFR, 1997 Comp., p. 217; E.O. 13599, 77 FR 6659, February 8, 2012; 
E.O. 13622, 77 FR 45897, August 2, 2012; E.O. 13628, 77 FR 62139, 
October 12, 2012.

Subpart D--Interpretations

0
2. Amend Sec.  560.405 by revising the note to paragraph (e) to read as 
follows:


Sec.  560.405  Transactions ordinarily incident to a licensed 
transaction authorized.

* * * * *

    Note to Paragraph (e) of Sec.  560.405:  See Sec.  560.530(a)(2) 
through (4) for general licenses authorizing, with certain 
exceptions, the exportation or reexportation of agricultural 
commodities, medicine, medical supplies, and replacement parts for 
certain medical devices to the Government of Iran, individuals or 
entities in Iran, or persons in third countries purchasing 
specifically for resale to any of the foregoing. These general 
licenses also authorize the conduct of related transactions, 
including, but not limited to, financing and payment, provided that 
payment terms and financing are limited to, and consistent with, 
Sec.  560.532, which sets forth payment terms for sales authorized 
by one of the general licenses set forth in paragraphs (a)(2) 
through (4) of Sec.  560.530 or by a specific license issued 
pursuant to paragraph (a)(1) of the same section.

Subpart E--Licenses, Authorizations and Statements of Licensing 
Policy

0
3. Amend Sec.  560.530 by revising paragraphs (a), (b), (c) 
introductory text, (c)(4) and (5), adding paragraph (d)(6), revising 
paragraphs (e)(1)(i), (e)(1)(ii) introductory text, (e)(2) introductory 
text, and (e)(3), and adding paragraph (e)(4) to read as follows:


Sec.  560.530  Commercial sales, exportation, and reexportation of 
agricultural commodities, medicine, and medical devices.

    (a)(1) One-year license requirement. (i) The exportation or 
reexportation of agricultural commodities, medicine, and medical 
devices that are not covered by the general licenses in paragraphs 
(a)(2) through (4) of this section (as set forth in paragraph 
(a)(1)(ii) of this section) to the Government of Iran, to any 
individual or entity in Iran, or to persons in third countries 
purchasing specifically for resale to any of the foregoing, shall only 
be made pursuant to a one-year specific license issued by the Office of 
Foreign Assets Control (``OFAC'') for contracts entered into during the 
one year period of the license and shipped within the 12-month period 
beginning on the date of the signing of the contract. No specific 
license will be granted for the exportation or reexportation of the 
items set forth in paragraph (a)(1)(ii) of this section to any entity 
or individual in Iran promoting international terrorism, to any 
individual or entity designated pursuant to Executive Order 12947 (60 
FR 5079, 3 CFR, 1995 Comp., p. 356), Executive Order 13224 (66 FR 
49079, 3 CFR, 2001 Comp., p. 786), or Public Law 104-132, to any 
narcotics trafficking entity designated pursuant to Executive Order 
12978 of October 21, 1995 (60 FR 54579, 3 CFR, 1995 Comp., p. 415) or 
the Foreign Narcotics Kingpin Designation Act (21 U.S.C. 1901-1908), or 
to any foreign organization, group, or persons subject to any 
restriction for its or their involvement in weapons of mass destruction 
or missile proliferation. Executory contracts entered into pursuant to 
paragraph (b)(2) of this section prior to the issuance of a one-year 
license described in this paragraph shall be deemed to have been signed 
on the date of issuance of that one-year license (and, therefore, the 
exporter is authorized to make shipments under that contract within the 
12-month period beginning on the date of issuance of the one-year 
license).
    (ii) For the purposes of this part, ``agricultural commodities, 
medicine, and medical devices that are not covered by the general 
licenses in paragraphs (a)(2) through (4) of this section'' are:
    (A) The excluded agricultural commodities specified in paragraph 
(a)(2)(ii) of this section;
    (B) The excluded medicines specified in paragraph (a)(3)(iii) of 
this section;
    (C) Medical devices (as defined in paragraph (e)(3) of this 
section) other than medical supplies (as defined in paragraph 
(a)(3)(ii) of this section); and
    (D) Agricultural commodities (as defined in paragraph (e)(1) of 
this section), medicine (as defined in paragraph (e)(2) of this 
section), and medical supplies (as defined in paragraph (a)(3)(ii) of 
this section) to military or law enforcement purchasers or importers.
    (2)(i) General license for the exportation or reexportation of 
agricultural commodities. Except as provided in paragraphs (a)(2)(ii) 
and (iii) of this section, the exportation or reexportation by a 
covered person (as defined in paragraph (e)(4) of this section) of 
agricultural commodities (as defined in paragraph (e)(1) of this 
section) (including bulk agricultural commodities listed in appendix B 
to this part) to the Government of Iran, to any individual or entity in 
Iran, or to persons in third countries purchasing specifically for 
resale to any of the foregoing, and the conduct of related 
transactions, including, but not limited to, the making of shipping and 
cargo inspection arrangements, the obtaining of insurance, the 
arrangement of financing and payment, shipping of the goods, receipt of 
payment, and the entry into contracts (including executory contracts), 
are hereby authorized, provided that, unless otherwise authorized by 
specific license, payment terms and financing for sales pursuant to 
this general license are limited to, and consistent with, those 
authorized by Sec.  560.532 of this part; and further provided that all 
such exports and reexports are shipped within the 12-month period 
beginning on the date of the signing of the contract for export or 
reexport.
    (ii) Excluded agricultural commodities. Paragraph (a)(2)(i) of this 
section does not authorize the exportation or reexportation of the 
following items: castor beans, castor bean seeds, certified pathogen-
free eggs (unfertilized or fertilized), dried egg albumin, live animals 
(excluding live cattle), embryos (excluding cattle embryos), Rosary/
Jequirity peas, non-food-grade gelatin powder, peptones and their 
derivatives, super absorbent polymers, western red cedar, or all 
fertilizers.
    (iii) Excluded persons. Paragraph (a)(2)(i) of this section does 
not authorize the exportation or reexportation of agricultural 
commodities to military or law enforcement purchasers or importers.

    Note to Paragraph (a)(2) of Sec.  560.530:  Consistent with 
section 906(a)(1) of the Trade Sanctions Reform and Export 
Enhancement Act of 2000 (22 U.S.C. 7205), each year OFAC will 
determine whether to revoke this general

[[Page 18994]]

license. Unless revoked, the general license will remain in effect.

    (3)(i) General license for the exportation or reexportation of 
medicine and medical supplies. Except as provided in paragraphs 
(a)(3)(iii) and (iv) of this section, the exportation or reexportation 
by a covered person (as defined in paragraph (e)(4) of this section) of 
medicine (as defined in paragraph (e)(2) of this section) and medical 
supplies (as defined in paragraph (a)(3)(ii) of this section) to the 
Government of Iran, to any individual or entity in Iran, or to persons 
in third countries purchasing specifically for resale to any of the 
foregoing, and the conduct of related transactions, including, but not 
limited to, the making of shipping and cargo inspection arrangements, 
the obtaining of insurance, the arrangement of financing and payment, 
shipping of the goods, receipt of payment, and the entry into contracts 
(including executory contracts), are hereby authorized, provided that, 
unless otherwise authorized by specific license, payment terms and 
financing for sales pursuant to this general license are limited to, 
and consistent with, those authorized by Sec.  560.532 of this part; 
and further provided that all such exports or reexports are shipped 
within the 12-month period beginning on the date of the signing of the 
contract for export or reexport.
    (ii) Definition of medical supplies. For purposes of this general 
license, the term medical supplies means those medical devices, as 
defined in paragraph (e)(3) of this section, that are included on the 
List of Medical Supplies on OFAC's Web site (www.treasury.gov/ofac) on 
the Iran Sanctions page.

    Note to Paragraph (a)(3)(ii) of Sec.  560.530: The List of 
Medical Supplies is maintained on OFAC's Web site (www.treasury.gov/ofac) on the Iran Sanctions page. The list also will be published in 
the Federal Register, as will any changes to the list. The List of 
Medical Supplies contains those medical devices for which OFAC 
previously did not require an Official Commodity Classification of 
EAR99 issued by the Department of Commerce's Bureau of Industry and 
Security to be submitted with a specific license application and 
which are now generally licensed.

    (iii) Excluded medicines. Paragraph (a)(3)(i) of this section does 
not authorize the exportation or reexportation of the following 
medicines: non-NSAID analgesics, cholinergics, anticholinergics, 
opioids, narcotics, benzodiazapenes, and bioactive peptides.
    (iv) Excluded persons. Paragraph (a)(3)(i) of this section does not 
authorize the exportation or reexportation of medicine or medical 
supplies to military or law enforcement purchasers or importers.

    Note to Paragraph (a)(3) of Sec.  560.530: Consistent with 
section 906(a)(1) of the Trade Sanctions Reform and Export 
Enhancement Act of 2000 (22 U.S.C. 7205), each year, OFAC will 
determine whether to revoke this general license. Unless revoked, 
the general license will remain in effect.

    (4) General license for the exportation or reexportation of 
replacement parts for certain medical devices. (i) The exportation or 
reexportation by a covered person (as defined in paragraph (e)(4) of 
this section) of replacement parts for medical devices (as defined in 
paragraph (e)(3) of this section) exported or reexported pursuant to 
paragraphs (a)(1) or (a)(3)(i) of this section to the Government of 
Iran, to any individual or entity in Iran, or to persons in third 
countries purchasing specifically for resale to any of the foregoing, 
and the conduct of related transactions, including, but not limited to, 
the making of shipping and cargo inspection arrangements, the obtaining 
of insurance, the arrangement of financing and payment, shipping of the 
goods, receipt of payment, and the entry into contracts (including 
executory contracts), are hereby authorized, provided that, unless 
otherwise authorized by specific license, payment terms and financing 
for sales pursuant to this general license are limited to, and 
consistent with, those authorized by Sec.  560.532 of this part; 
provided that such replacement parts are designated as EAR99, or, in 
the case of replacement parts that are not subject to the Export 
Administration Regulations, 15 CFR parts 730 et seq. (``EAR''), would 
be designated as EAR99 if they were located in the United States; and 
further provided that such replacement parts are limited to a one-for-
one export or reexport basis (i.e., only one replacement part can be 
exported or reexported to replace a broken or non-operational 
component).
    (ii) Excluded persons. Paragraph (a)(4)(i) of this section does not 
authorize the exportation or reexportation of replacement parts for 
medical devices to military or law enforcement purchasers or importers.

    Note to Paragraph (a)(4) of Sec.  560.530: Consistent with 
section 906(a)(1) of the Trade Sanctions Reform and Export 
Enhancement Act of 2000 (22 U.S.C. 7205), each year, OFAC will 
determine whether to revoke this general license. Unless revoked, 
the general license will remain in effect.

    (b) General license for arrangement of exportation and 
reexportation of covered products that require a specific license. (1) 
With respect to sales authorized pursuant to paragraph (a)(1)(i) of 
this section, the making of shipping arrangements, cargo inspections, 
obtaining of insurance, and arrangement of financing (consistent with 
Sec.  560.532) for the exportation or reexportation of agricultural 
commodities, medicine, and medical devices that are not covered by the 
general licenses in paragraphs (a)(2) through (4) of this section (as 
set forth in paragraph (a)(1)(ii) of this section) to the Government of 
Iran, to any individual or entity in Iran, or to persons in third 
countries purchasing specifically for resale to any of the foregoing, 
are authorized.
    (2) Entry into executory contracts (including executory pro forma 
invoices, agreements in principle, or executory offers capable of 
acceptance such as bids in response to public tenders) for the 
exportation or reexportation of agricultural commodities, medicine, and 
medical devices that are not covered by the general licenses in 
paragraphs (a)(2) through (4) of this section (as set forth in 
paragraph (a)(1)(ii) of this section) to the Government of Iran, to any 
individual or entity in Iran, or to persons in third countries 
purchasing specifically for resale to any of the foregoing, is 
authorized, provided that the performance of an executory contract is 
expressly made contingent upon the prior issuance of a one-year 
specific license described in paragraph (a)(1)(i) of this section.
    (c) Instructions for obtaining one-year licenses. In order to 
obtain the one-year specific license described in paragraph (a)(1)(i) 
of this section, the exporter must provide to OFAC:
* * * * *
    (4) A description of all items to be exported or reexported 
pursuant to the requested one-year license, including a statement that 
the items are designated as EAR99, or would be designated as EAR99 if 
they were located in the United States, and, if necessary, 
documentation sufficient to verify that the items to be exported or 
reexported are designated as EAR99, or would be designated as EAR99 if 
they were located in the United States, and do not fall within any of 
the limitations contained in paragraph (d) of this section; and
    (5) For items subject to the EAR, an Official Commodity 
Classification of EAR99 issued by the Department of Commerce's Bureau 
of Industry and Security (``BIS''), certifying that the product is 
designated as EAR99, is

[[Page 18995]]

required to be submitted to OFAC with the request for a license 
authorizing the exportation or reexportation of all fertilizers, live 
horses, western red cedar, or medical devices other than medical 
supplies (as defined in Sec.  560.530(a)(3)(ii)). See 15 CFR 745.3 for 
instructions for obtaining an Official Commodity Classification of 
EAR99 from BIS.
    (d) * * *
    (6) Nothing in this section or in any general or specific license 
set forth in or issued pursuant to paragraph (a) of this section 
authorizes the exportation or reexportation of any agricultural 
commodity, medicine, or medical device that is not designated as EAR99 
or, in the case of any agricultural commodity, medicine, or medical 
device not subject to the EAR, would not be designated as EAR99 if it 
were located in the United States.
    (e) * * *
    (1) * * *
    (i) In the case of products subject to the EAR, 15 CFR part 774, 
products that are designated as EAR99, and, in the case of products not 
subject to the EAR, products that would be designated as EAR99 under 
the EAR if they were located in the United States, in each case that 
fall within the term ``agricultural commodity'' as defined in section 
102 of the Agricultural Trade Act of 1978 (7 U.S.C. 5602); and
    (ii) In the case of products subject to the EAR, products that are 
designated as EAR99, and in the case of products not subject to the 
EAR, products that would be designated as EAR99 if they were located in 
the United States, in each case that are intended for ultimate use in 
Iran as:
* * * * *
    (2) Medicine. For the purposes of this part, medicine is an item 
that falls within the definition of the term ``drug'' in section 201 of 
the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) and that, in 
the case of an item subject to the EAR, is designated as EAR99 or, in 
the case of an item not subject to the EAR, that would be designated as 
EAR99, if it were located in the United States.
* * * * *
    (3) Medical device. For the purposes of this part, a medical device 
is an item that falls within the definition of ``device'' in section 
201 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 321) and 
that, in the case of an item subject to the EAR, is designated as 
EAR99, or in the case of an item not subject to the EAR, that would be 
designated as EAR99 if it were located in the United States.
    (4) Covered person. For purposes of this part, a covered person is, 
with respect to the exportation or reexportation of items subject to 
the EAR, a U.S. person or a non-U.S. person, and for purposes of items 
not subject to the EAR, a U.S. person, wherever located, or an entity 
owned or controlled by a U.S. person and established or maintained 
outside the United States.
* * * * *

0
4. Amend Sec.  560.533 by revising paragraphs (a) and (b) to read as 
follows:


Sec.  560.533  Brokering sales of agricultural commodities, medicine, 
and medical devices.

    (a) General license for brokering sales by U.S. persons. United 
States persons are authorized to provide brokerage services on behalf 
of U.S. persons for the sale and exportation or reexportation by U.S. 
persons of agricultural commodities, medicine, and medical devices, 
provided that the sale and exportation or reexportation is authorized, 
as applicable, by a one-year specific license issued pursuant to 
paragraph (a)(1)(i) of Sec.  560.530 or by one of the general licenses 
set forth in paragraphs (a)(2), (a)(3), and (a)(4) of Sec.  560.530.
    (b) Specific licensing for brokering sales by non-U.S. persons of 
agricultural commodities. Specific licenses may be issued on a case-by-
case basis to permit U.S. persons to provide brokerage services on 
behalf of non-U.S., non-Iranian persons for the sale and exportation or 
reexportation of agricultural commodities to the Government of Iran, 
entities in Iran, or individuals in Iran. Specific licenses issued 
pursuant to this section will authorize the brokering only of sales 
that are to purchasers permitted pursuant to Sec.  560.530.

    Note To Paragraph (b) of Sec.  560.533:  Requests for specific 
licenses to provide brokerage services under this paragraph must 
include all of the information described in Sec.  560.530(c).

* * * * *

    Dated: March 31, 2014.
Adam J. Szubin,
Director, Office of Foreign Assets Control.
[FR Doc. 2014-07572 Filed 4-4-14; 8:45 am]
BILLING CODE P