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class="item-736"><a href="/index.php/regulations/order-a-hard-copy-of-the-ear" >Order a Hard Copy of the EAR</a></li><li class="item-901"><a href="https://efoia.bis.doc.gov/index.php/electronic-foia/index-of-documents" onclick="window.open(this.href, 'targetWindow', 'toolbar=no,location=no,status=no,menubar=no,scrollbars=yes,resizable=yes,'); return false;">Proposed Rule Public Comments</a></li></ul></li><li class="item-130 deeper parent"><a href="/index.php/compliance-a-training" >Compliance & Training</a><ul class="nav-child unstyled small"><li class="item-209"><a href="/index.php/compliance-a-training/current-seminar-schedule" >Current Seminar Schedule</a></li><li class="item-204 divider deeper parent"><span class="separator ">Export Management and Compliance</span> <ul class="nav-child unstyled small"><li class="item-206"><a href="/index.php/compliance-a-training/export-management-a-compliance/compliance" >Compliance</a></li><li class="item-208"><a 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href="https://www.bis.doc.gov/index.php/policy-guidance/faqs" >ECR FAQs</a></li><li class="item-218"><a href="/index.php/compliance-a-training/export-administration-regulations-training/make-a-seminar-inquiry-western-region" >Make a Seminar Inquiry -- Western Region</a></li><li class="item-224"><a href="/index.php/compliance-a-training/export-administration-regulations-training/contact-a-counselor-western-region" >Contact a Counselor -- Western Region</a></li><li class="item-222"><a href="/index.php/compliance-a-training/export-administration-regulations-training/make-a-seminar-inquiry-eastern-region" >Make a Seminar Inquiry -- Eastern Region</a></li><li class="item-223"><a href="/index.php/compliance-a-training/export-administration-regulations-training/contact-a-counselor-eastern-region" >Contact a Counselor -- Eastern Region</a></li><li class="item-798"><a href="/index.php/compliance-a-training/export-administration-regulations-training/aes-compliance-training" >BIS/Census AES Compliance Training</a></li><li class="item-1218"><a href="/index.php/compliance-a-training/export-administration-regulations-training/2023-update-conference" >Update Conference</a></li></ul></li></ul></li><li class="item-133 active deeper parent"><a href="/index.php/policy-guidance" >Policy Guidance</a><ul class="nav-child unstyled small"><li class="item-237 deeper parent"><a href="/index.php/policy-guidance/deemed-exports" >Deemed Exports</a><ul class="nav-child unstyled small"><li class="item-239"><a href="/index.php/policy-guidance/deemed-exports/deemed-exports-faqs" >Deemed Exports FAQs</a></li><li class="item-835"><a href="/index.php/policy-guidance/deemed-exports/deemed-reexport-guidance1" >Deemed Reexport Guidance </a></li><li class="item-241"><a href="/index.php/component/docman/policy-guidance/product-guidance/chemical-and-biological-controls?task=doc_download&gid=709" >Guidelines for Foreign National License Applications</a></li><li class="item-1153"><a href="https://www.bis.doc.gov/index.php/online-training-room" >Deemed Export Video</a></li></ul></li><li class="item-1204"><a href="/index.php/policy-guidance/advanced-computing-and-semiconductor-manufacturing-items-controls-to-prc" >Advanced Computing and Semiconductor Manufacturing Items Controls to PRC</a></li><li class="item-857"><a href="/index.php/policy-guidance/faqs" >FAQs</a></li><li class="item-873 deeper parent"><a href="/index.php/policy-guidance/foreign-import-export-license-requirements" >Foreign Import/Export License Requirements </a><ul class="nav-child unstyled small"><li class="item-228"><a href="/index.php/policy-guidance/foreign-import-export-license-requirements/hong-kong" >Hong Kong</a></li><li class="item-871"><a href="/index.php/policy-guidance/foreign-import-export-license-requirements/singapore" >Singapore</a></li><li class="item-872"><a href="/index.php/policy-guidance/foreign-import-export-license-requirements/united-arab-emirates" >United Arab Emirates</a></li></ul></li><li class="item-238 deeper parent"><a href="/index.php/policy-guidance/encryption" >Encryption and Export Administration Regulations (EAR)</a><ul class="nav-child unstyled small"><li class="item-714"><a href="/index.php/policy-guidance/encryption/1-encryption-items-not-subject-to-the-ear" >1. Encryption items NOT Subject to the EAR </a></li><li class="item-252 divider deeper parent"><span class="separator ">2. Items in Cat. 5, Part 2</span> <ul class="nav-child unstyled small"><li class="item-1071 divider deeper parent"><span class="separator ">a. 5A002.a (and 5D002 c.1) </span> <ul class="nav-child unstyled small"><li class="item-1078"><a href="/index.php/policy-guidance/encryption/2-items-in-cat-5-part-2/a-5a002-a-and-5d002-c-1/i-cryptography-for-data-confidentiality" >i. Cryptography for Data Confidentiality </a></li><li class="item-1076"><a href="/index.php/policy-guidance/encryption/2-items-in-cat-5-part-2/a-5a002-a-and-5d002-c-1/ii-key-length" >ii. Key Length</a></li><li class="item-1118"><a href="/index.php/policy-guidance/encryption/2-items-in-cat-5-part-2/a-5a002-a-and-5d002-c-1/iii-cryptographic-activation" >iii. Cryptographic Activation</a></li><li class="item-1077"><a href="/index.php/policy-guidance/encryption/2-items-in-cat-5-part-2/a-5a002-a-and-5d002-c-1/iv-5a002-a-1-a-4" >iv. 5A002 a.1- a.4 </a></li><li class="item-1079"><a href="/index.php/policy-guidance/encryption/2-items-in-cat-5-part-2/a-5a002-a-and-5d002-c-1/v-decontrol-notes" >v. Decontrol Notes</a></li></ul></li></ul></li><li class="item-1072 divider deeper parent"><span class="separator ">3. License Exception ENC and Mass Market</span> <ul class="nav-child unstyled small"><li class="item-1080"><a href="/index.php/policy-guidance/encryption/3-license-exception-enc-and-mass-market/a-mass-market" >a. Mass Market</a></li><li class="item-1081"><a href="/index.php/policy-guidance/encryption/3-license-exception-enc-and-mass-market/b-740-17-a" >b. 740.17(a) </a></li><li class="item-1082"><a href="/index.php/policy-guidance/encryption/3-license-exception-enc-and-mass-market/c-740-17-b-2" >c. 740.17(b)(2)</a></li><li class="item-1083"><a href="/index.php/policy-guidance/encryption/3-license-exception-enc-and-mass-market/d-740-17-b-3" >d. 740.17(b)(3)</a></li><li class="item-1084"><a href="/index.php/policy-guidance/encryption/3-license-exception-enc-and-mass-market/e-740-17-b-1" >e. 740.17(b)(1)</a></li></ul></li><li class="item-1073 divider deeper parent"><span class="separator ">4. Reports and Reviews</span> <ul class="nav-child unstyled small"><li class="item-1085"><a href="/index.php/policy-guidance/encryption/4-reports-and-reviews/a-annual-self-classification" >a. Annual Self-Classification</a></li><li class="item-1086"><a href="/index.php/policy-guidance/encryption/4-reports-and-reviews/b-semi-annual-sales-report" >b. Semi-Annual Sales Report</a></li><li class="item-1087"><a href="/index.php/policy-guidance/encryption/4-reports-and-reviews/c-encryption-review-ccats" >c. Encryption Review (CCATS)</a></li></ul></li><li class="item-1074 divider deeper parent"><span class="separator ">5. Licenses</span> <ul class="nav-child unstyled small"><li class="item-1088"><a href="/index.php/policy-guidance/encryption/5-licenses/a-when-a-license-is-required" >a. When a license is required</a></li><li class="item-1089"><a href="/index.php/policy-guidance/encryption/5-licenses/b-types-of-licenses" >b. Types of Licenses</a></li><li class="item-1090"><a href="/index.php/policy-guidance/encryption/5-licenses/c-how-to-file" >c. How to File</a></li></ul></li><li class="item-827"><a href="/index.php/policy-guidance/encryption/6-faqs" >6. 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href="/index.php/policy-guidance/product-guidance/chemical-and-biological-controls?id=566">Classification Requests -- Medical Items</a></p> <p><a href="/index.php/cbc-eccns">CBC ECCNs</a></p> <p><a href="/index.php/staff-directory">Staff Directory</a></p></div> </div> </div> </div> </div> <div class="clr"></div> <span class="shadow-left"> </span> <span class="shadow-right"> </span> </div> </div> <div id="content_outleft"> <div id="maincontent">  <div id="system-message-container"> </div> <script type="text/javascript"> function currentvideo(id, title, descr) { var xmlhttp; if (window.XMLHttpRequest) { xmlhttp = new XMLHttpRequest(); } else { xmlhttp = new ActiveXObject("Microsoft.XMLHTTP"); } xmlhttp.onreadystatechange = function() { if (xmlhttp.readyState == 4 && xmlhttp.status == 200) { } } xmlhttp.open("GET", "index.php?option=com_hdflvplayer&task=addview&thumbid=" + id, true); xmlhttp.send(); var wndo = new dw_scrollObj('wn', 'lyr1'); wndo.setUpScrollbar("dragBar", "track", "v", 1, 1); wndo.setUpScrollControls('scrollbar'); } </script> <div class="item-page" itemscope itemtype="https://schema.org/Article"> <meta itemprop="inLanguage" content="en-GB" /> <div class="page-header"> <h2 itemprop="headline"> TSRA LICENSING - CLASSIFICATION REQUESTS FOR MEDICAL AND AGRICULTURAL ITEMS </h2> </div> <div itemprop="articleBody"> <p><strong><img alt="" src="/images/sampledata/chemical3.jpg" />TSRA LICENSING - CLASSIFICATION REQUESTS FOR MEDICAL AND AGRICULTURAL ITEMS </strong></p> <p dir="LTR" align="LEFT">This section provides exporters with additional guidance on how to apply for a Commodity Classification from the Department of Commerce, Bureau of Industry and Security (BIS) to support for a license authorization for export and reexport to Iran and Sudan from the Office of Foreign Assets Control (OFAC) at the Department of Treasury. The Trade Sanctions Reform and Export Enhancement Act of 2000, Title IX of Public Law 106 387 (October 28, 2000) (the "TSRA"), provides that the President shall terminate any unilateral agricultural sanction or unilateral medical sanction in effect as of the date of enactment of the TSRA.</p> <p>On October 12, 2011, OFAC amended the Sudanese Sanctions Regulations, 31 CFR Part 538, and the Iranian Transactions Regulations, 31 CFR part 560, by issuing general licenses that authorize the exportation or reexportation of most food items to individuals and entities in Sudan (other than the Specified Areas of Sudan) and in Iran</p> <p>On October 22, 2012, OFAC amended the former Iranian Transactions Regulations(now called the Iranian Transactions and Sanctions Regulations ("ITSR")), 31 CFR part 560, to add a general license authorizing the exportation or reexportation of medicine and basic medical supplies to Iran. OFAC has provided a definition for what qualifies as medicine and has provided a list of "basic medical supplies" that are eligible for a general license authorization on its website. These general licenses do not authorize the export or reexport of food, medicine, or basic medical supplies to military or law enforcement purchasers or importers.</p> <p>On April 7, 2014, the Department of the Treasury's Office of Foreign Assets Control (OFAC) issued updated FAQs on Iran/TSRA General Licenses, which pertain to 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.</p> <p>On December 23, 2016, The Department of the Treasury’s Office of Foreign Assets Control (OFAC) amended the Iranian Transactions and Sanctions Regulations(<a href="https://www.gpo.gov/fdsys/pkg/FR-2016-12-23/pdf/2016-30968.pdf">https://www.gpo.gov/fdsys/pkg/FR-2016-12-23/pdf/2016-30968.pdf</a>)  31 C.F.R. part 560 (ITSR) to expand the scope of medical devices and agricultural commodities generally authorized for export or reexport to Iran pursuant to the Trade Sanctions Reform and Export Enhancement Act of 2000, as amended.  This amendment also includes new or expanded authorizations related to training, replacement parts, software and services for the operation, maintenance, and repair of medical devices, and items that are broken or connected to product recalls or other safety concerns.  Additionally, this amendment revises the definition of the terms “goods of Iranian origin” and “Iranian-origin goods."</p> <p><span>NOTE:  OFAC amended the existing general license in §560.530(a)(3) relating to authorized exports or reexports  of certain medical  devices specified on the List of Medical Supplies.  As amended, the general license has been expanded to authorize the exportation or reexportation to Iran of all items meeting the definition of the term “medical device” as set forth in §560.530(e)(3), except for certain medical devices that are explicitly excluded from the authorization as specified in a new <a href="https://www.treasury.gov/resource-center/sanctions/Programs/Documents/iran_gl_med_supplies.pdf">List of Medical Devices Requiring Specific Authorization</a>, which is maintained on OFAC’s website on the Iran Sanctions page, as set forth in revised §560.530(a)(3)(ii).    The exportation and reexportation of the specified excluded medical devices requires specific authorization from OFAC, as reflected in amended §560.530(a)(1)(ii)(C). Medical devices other than those specified on the new List of Medical Devices Requiring Specific Authorization may be exported or reexported to Iran without separate authorization from OFAC.</span></p> <p><strong>To determine if your item requires a Commodity Classification (CCAT), please consult OFAC’s webpage:</strong><br /><br /><a href="https://www.treasury.gov/resource-center/sanctions/Programs/Pages/tsra.aspx">Frequently Asked Questions on Iran/TSRA General Licenses </a><br /><br /><strong>How to apply for a Commodity Classification:<a href="/index.php/forms-documents/regulations-docs/143-bis-eccn-pdf/file"></a></strong></p> <p><a href="/index.php/forms-documents/regulations-docs/143-bis-eccn-pdf/file">BIS ECCN Brochure</a></p> <p><strong>Medical CCAT specific tips:</strong></p> <p>For other than simple items please provide a product brochure. <br /><br />Please state if the CCAT is for an OFAC license.<br /><br />If your product has an FDA # please provide it.<br /><br /></p> <p><strong>NOTE:<br /></strong><br />The FDA regulates drugs of abuse test kits as medical devices, specifically in vitro diagnostics (IVDs). For Drugs of Abuse Tests visit <a href="http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/DrugsofAbuseTests/default.htm">http://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/InVitroDiagnostics/DrugsofAbuseTests/default.htm</a>  for the various product classifications for  IVDs. To receive an EAR99 medical classification exporters must provide documentation that the FDA has classified the drugs of abuse test kits as a medical device marketable in the United States. Please consult the FDA website for more information.<br /><br />Diagnostic tests for food or water borne pathogens are regulated by the  Center for Food Safety and Applied Nutrition (CFSAN)  and are not medical devices</p> <p> </p> </div> </div>  </div> <div class="clr"></div> <span class="shadow-left"> </span> <span class="shadow-right"> </span> </div> <div class="clr"></div> </div> <div class="clr"></div> </div> <div id="foot_container" style="max-width:1180px;"> <div id="subfoot"> <div class="copytext">© BIS 2024</div> </div> <div class="clr"></div> <div id="footer"> <div class="footer-inner"> <span class="feckl"> </span> <span class="feckr"> </span> <div id="scroll_up"> <a class="lv-tooltip" id="gotop" title="Scroll to top">↑↑↑</a></div> <div id="footermodule1234"> </div> <div id="footermodule5"> <div class="moduletable"> <div class="custom" > <script src="https://touchpoints.app.cloud.gov/touchpoints/f64537c4.js" async="" type="text/javascript"></script> <p> </p> <p style="text-align: center;"><strong><a href="http://efoia.bis.doc.gov">FOIA </a> |  <a href="/index.php/disclaimer">Disclaimer</a>  | <a href="/index.php/disclaimer/27-about-bis/174-bis-privacy-policy-statement"> Privacy Policy</a> <strong>|  </strong></strong><strong><a class="doclink" href="/index.php/component/docman/?task=doc_download&gid=1562&Itemid=182">SORN</a></strong><strong>  |  <a class="doclink" href="/index.php/component/docman/?task=doc_download&gid=236&Itemid=182">Information Quality</a> |   <a href="http://www.commerce.gov/open">Open Government Plan</a> | <a href="https://www.commerce.gov/about/strategic-plan">Strategic Plan </a>| <a href="http://www.osec.doc.gov/bmi/budget/FY2006APP.htm">Annual </a><a href="https://www.commerce.gov/about/budget-and-performance">Performance Plan</a></strong><strong></strong></p> <center><strong><a id="DOC" href="/urlmessages/leavingBIS.php?destination=http:%2F%2Fwww.doc.gov/">Department of Commerce</a>  |  <a href="/urlmessages/leavingBIS.php?destination=http:%2F%2Fwww.usajobs.gov/">BIS Jobs</a>  |  <a href="/urlmessages/leavingBIS.php?destination=https:%2F%2Fwww.commerce.gov/cr/reports-and-resources/no-fear-act">No FEAR ACT</a>  |  <a href="/urlmessages/leavingBIS.php?destination=http:%2F%2Fwww.usa.gov/">USA.gov</a>  |  <a href="/index.php/about-bis/contact-bis">Contact Us</a>  | </strong></center></div> </div> </div> </div> <div class="footer-bottom"> </div> </div> <div class="clr"></div> </div> </body> </html>