{"id":13894,"date":"2024-07-10T11:28:38","date_gmt":"2024-07-10T15:28:38","guid":{"rendered":"https:\/\/research.ncsu.edu\/administration\/?page_id=13894"},"modified":"2026-02-02T15:03:50","modified_gmt":"2026-02-02T20:03:50","slug":"federally-funded-research","status":"publish","type":"page","link":"https:\/\/research.ncsu.edu\/administration\/compliance\/research-compliance\/irb\/federally-funded-research\/","title":{"rendered":"Federally Funded Research"},"content":{"rendered":"\n\n\n\n\n<h2 class=\"wp-block-heading\">Federal Sponsors<\/h2>\n\n\n<div class=\"is-text wp-block-ncst-accordion\" >\n    <div class=\"accordion isLinked\" id=\"ncst-accordion-jq84f5\">\n          \n<details class=\"wp-block-ncst-accordion-item\" name=\"jq84f5\"  >\n      <summary class=\"accordion-item__header\">\n        <span class=\"accordion-item__expansion-indicator\">\n          <span class=\"ncst-plus-minus-toggle\"><\/span>\n        <\/span>\n        <h2 class=\"accordion-item__label h6\">Department of Defense (DoD)<\/h2>\n      <\/summary>\n      <p>\n        \n\n<p>In addition to the Code of Federal Regulations (<a href=\"https:\/\/www.ecfr.gov\/on\/2018-07-19\/title-45\/subtitle-A\/subchapter-A\/part-46\" target=\"_blank\" rel=\"noreferrer noopener\">45 CFR 46<\/a>) governing research with human subjects, any research funded by or research that uses DoD resources, is subject to additional regulations. These include <a href=\"https:\/\/drive.google.com\/file\/d\/16khE42gXuP21_ZhyTF9ZcYF-BNOeAHRA\/view\" target=\"_blank\" rel=\"noreferrer noopener\">32 CFR 219<\/a>  and the subsequent <a href=\"https:\/\/www.esd.whs.mil\/Portals\/54\/Documents\/DD\/issuances\/dodi\/321602p.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">DoD Instruction 3216.02<\/a>. These requirements are synthesized together in the <a href=\"https:\/\/docs.google.com\/document\/d\/16IKH6EbO_rKxTyCcWH7bF0eBPwUMlL-u\/edit#heading=h.gjdgxs\" target=\"_blank\" rel=\"noreferrer noopener\">NC State University IRB unit standard on DoD affiliated research projects<\/a>.<\/p>\n\n\n\n<p>Additional obligations for researchers completing research activities funded or supported by the DoD include a Scientific Merit Review, HRPO review, and providing additional Information in the Informed Consent form and IRB Protocol.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>A Scientific Merit Review: This occurs as part of the initial IRB review and approval process (<a href=\"https:\/\/www.esd.whs.mil\/Portals\/54\/Documents\/DD\/issuances\/dodi\/321602p.pdf\" target=\"_blank\" rel=\"noreferrer noopener\">DoDI.3.5.a.5<\/a>). This should be carried out by someone unaffiliated with the study and it should include an assessment of the study\u2019s scientific merit and the feasibility of study completion. Documentation of this review can be a letter from an expert or a completed NC State University <a href=\"https:\/\/drive.google.com\/file\/d\/1DJXSTtrAJqqDMVB8EF4zKdzwhEeNAns7\/view\" target=\"_blank\" rel=\"noreferrer noopener\">scientific merit form<\/a>. To see how and when this applies to a research protocol associated with the Department of Defense, please review the <a href=\"https:\/\/docs.google.com\/document\/d\/16IKH6EbO_rKxTyCcWH7bF0eBPwUMlL-u\/edit#heading=h.gjdgxs\" target=\"_blank\" rel=\"noreferrer noopener\">NC State IRB unit standard on DoD affiliated research projects<\/a>.&nbsp;<\/li>\n\n\n\n<li>A Secondary Review called \u201cHRPO Review\u201d: After NC State University IRB review and approval has occurred, all DoD-affiliated research projects must undergo HRPO review regardless of the level of review assigned by the NC State University IRB. This type of review is carried out by the DoD\u2019s Human Research Protection Office (HRPO). This type of review is required for all research subject to the DoD regulations. This review is not carried out by the NC State IRB office, though you will need to submit your NC State IRB-approved materials to HRPO after NC State IRB approves the study.&nbsp;<\/li>\n\n\n\n<li>Additional Requirements: Research funded or supported by the DoD have additional requirements for the Informed Consent form, necessary information in the IRB application, and for \u201cmore than minimal risk\u201d research, additional personnel and guardrails are required. Please review the NC State University&#8217;s IRB\u2019s unit standard <a href=\"https:\/\/docs.google.com\/document\/d\/16IKH6EbO_rKxTyCcWH7bF0eBPwUMlL-u\/edit\" target=\"_blank\" rel=\"noreferrer noopener\">Research with the Department of Defense<\/a>.<\/li>\n<\/ul>\n\n\n      <\/p>\n  <\/details>\n\n\n<details class=\"wp-block-ncst-accordion-item\" name=\"jq84f5\"  >\n      <summary class=\"accordion-item__header\">\n        <span class=\"accordion-item__expansion-indicator\">\n          <span class=\"ncst-plus-minus-toggle\"><\/span>\n        <\/span>\n        <h2 class=\"accordion-item__label h6\">National Institutes for Health (NIH)<\/h2>\n      <\/summary>\n      <p>\n        \n\n<p>In addition to the Code of Federal Regulations (<a href=\"https:\/\/www.ecfr.gov\/on\/2018-07-19\/title-45\/subtitle-A\/subchapter-A\/part-46\" target=\"_blank\" rel=\"noreferrer noopener\">45 CFR 46<\/a>) governing research with human subjects, any research funded by the NIH is subject to additional rules from NIH. For detailed guidance about the NIH and human subjects research, please review the NC State University\u2019s IRB\u2019s guidance <a href=\"https:\/\/docs.google.com\/document\/d\/1bho1Fpadb075_YNyd7cfMz0cUYODP-bL\/edit#heading=h.mvgwxgf05cw8\" target=\"_blank\" rel=\"noreferrer noopener\">NIH Grants and the IRB<\/a> (Word document)<\/p>\n\n\n\n<p>Additional obligations for researchers completing research activities funded by the NIH on or after January 25, 2023 include:<\/p>\n\n\n\n<h3 class=\"wp-block-heading\">Data Management and Sharing Plan<\/h3>\n\n\n\n<p>Effective January 25, 2023, the NIH issued the final NIH Policy for Data Management and Sharing (DMS Policy) to promote the management and sharing of scientific data generated from NIH-funded or conducted research. This policy established the requirements for submitting \u201cData Management and Sharing Plans.\u201d NIH\u2019s Data Management and Sharing Policy (DMSP) emphasizes the importance of quality data management practices and establishes the expectation for maximizing the appropriate sharing of scientific data generated from NIH-funded or conducted research, with justified limitations or exceptions. For details, please refer to the <a href=\"https:\/\/docs.google.com\/document\/d\/1bho1Fpadb075_YNyd7cfMz0cUYODP-bL\/edit#heading=h.3tk3yyivpjl6\" target=\"_blank\" rel=\"noreferrer noopener\">NIH Grants and the IRB Guidance, pages 5-12<\/a>. To ensure compliance with this rule, the NC State IRB has required the following actions to occur:<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>The completed DMSP must be uploaded to the IRB application for review and consideration during IRB approval.&nbsp;<\/li>\n\n\n\n<li>If the data accessed or generated as a part of the NIH sponsored study is considered highly sensitive (red) or ultra sensitive (purple), an NC state IRB \u201cData Access and Security Plan\u201d must be submitted to the IRB for review. This plan is completed with NC State&#8217;s Security and Compliance office and should be consistent with the DMSP required by the NIH. This access and security plan is NC State specific and it should operationalize your stated DMSP that you submit to the NIH. To request a data and access security plan for your IRB protocol, please complete the <a href=\"https:\/\/ncsu.service-now.com\/sp?id=sc_cat_item&amp;sys_id=eb9cb46f1bb5d91039f40ed6624bcb8c&amp;sysparm_category=c255605f1b01a0d04d506288bd4bcb1f\" target=\"_blank\" rel=\"noreferrer noopener\">request via the Service Now Portal<\/a>.<\/li>\n\n\n\n<li>Annual renewal approval or check-in with the NC State IRB office: Due to the yearly reporting requirements from the NIH, the NC State IRB assigns an \u201capproval expiration date\u201d to all studies, including exemptions. This means that if there is an approval expiration date, the researcher must apply to the IRB for approval renewal BEFORE the expiration date of the protocol. Please submit the <a href=\"https:\/\/research.ncsu.edu\/administration\/files\/2025\/09\/Renewal-Request-Supplement-\u2013-NIH-Funded-Protocols.docx\" target=\"_blank\" rel=\"noreferrer noopener\">Renewal Request NIH Supplement Form<\/a> for your annual approval renewal via the electronic IRB system. If your study was reviewed by the Full Board, the NIH Supplement Form should be uploaded in addition to completing the annual renewal request form on eIRB.&nbsp;<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Just In Time (JIT)<\/h3>\n\n\n\n<p>The NIH utilizes the \u201cjust-in-time\u201d process for certain programs and award mechanisms. JIT refers to the application timeframe in which applicants are required to submit updated time-sensitive information to the NIH only if an award is likely.&nbsp;The JIT notice usually includes a request for content that was not included in the initial application, such as IRB approval.&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>If your grant application receives a just-in-time notice, you still need to submit a completed IRB protocol and related documents, including the NIH\u2019s Data Management and Sharing Plan (DMSP), for review to the NC State IRB.<\/li>\n\n\n\n<li>To apply for a Just-In-Time review, please refer to the <a href=\"https:\/\/docs.google.com\/document\/d\/1bho1Fpadb075_YNyd7cfMz0cUYODP-bL\/edit#heading=h.3tk3yyivpjl6\" target=\"_blank\" rel=\"noreferrer noopener\">NIH Grants and the IRB guidance<\/a> for an overview of the process and submit the initial JIT request to the IRB office via the eIRB system.&nbsp;<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Use of the Single IRB (sIRB)<\/h3>\n\n\n\n<p>The NIH policy on the use of a single institutional review board of record for multi-site research establishes the expectation that all sites participating in multi-site studies involving non-exempt human subjects research funded by the NIH will use a single Institutional Review Board (sIRB).&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>The NIH sIRB policy only applies to the domestic sites of NIH-funded multi-site studies.&nbsp;<\/li>\n\n\n\n<li>Multi-site studies under this policy means each site will conduct the same protocol. Protocols that address the same research question(s), involve the same methodologies, and evaluate the same outcomes are considered to be the \u201csame research protocol\u201d.&nbsp;<\/li>\n\n\n\n<li>The multi-site studies affected by this policy involve non-exempt human subjects research, whether supported through grants, cooperative agreements, contracts, or the NIH Intramural Research Program.&nbsp;<\/li>\n\n\n\n<li>For guidance on selecting a lead site (whose IRB will be the IRB of record that will review the project) please refer to the <a href=\"https:\/\/docs.google.com\/document\/d\/1bho1Fpadb075_YNyd7cfMz0cUYODP-bL\/edit#heading=h.3tk3yyivpjl6\" target=\"_blank\" rel=\"noreferrer noopener\">NIH Grants and the IRB Guidance, page 3<\/a>.<\/li>\n\n\n\n<li>For details regarding cooperative research and formal agreements between and among IRBs, please review the NC State University\u2019s IRB\u2019s \u201c<a href=\"https:\/\/research.ncsu.edu\/administration\/compliance\/research-compliance\/irb\/cooperative-research\/\">Cooperative Research<\/a>\u201d webpage.&nbsp;<\/li>\n<\/ul>\n\n\n\n<h3 class=\"wp-block-heading\">Institutional Certification<\/h3>\n\n\n\n<p>This certification assures NIH that submission of large-scale human genomic data to an NIH-designated data repository is consistent with the NIH Genomic Data Sharing Policy, the NIH Data Management and Sharing Policy, the informed consent of the original study participants, and\/or the preferences of the original study population. The certification also states whether, after IRB review, research use limitation is deemed necessary.&nbsp;<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>The Institutional Certification will be requested as part of the JIT process and is required for award. The Institutional Certification is provided by the submitting investigator and the NC State Institutional Official (IO).<\/li>\n\n\n\n<li>The Institutional Certification, or in some cases, a provisional Institutional Certification, must be submitted and accepted before the award can be issued. Please refer to the <a href=\"https:\/\/docs.google.com\/document\/d\/1bho1Fpadb075_YNyd7cfMz0cUYODP-bL\/edit#heading=h.3tk3yyivpjl6\">NIH Grants and the IRB Guidance, page 8<\/a> for details.&nbsp;<\/li>\n<\/ul>\n\n\n      <\/p>\n  <\/details>\n\n\n<details class=\"wp-block-ncst-accordion-item\" name=\"jq84f5\"  >\n      <summary class=\"accordion-item__header\">\n        <span class=\"accordion-item__expansion-indicator\">\n          <span class=\"ncst-plus-minus-toggle\"><\/span>\n        <\/span>\n        <h2 class=\"accordion-item__label h6\">National Science Foundation (NSF)<\/h2>\n      <\/summary>\n      <p>\n        \n\n<p>In addition to the Code of Federal Regulations (<a href=\"https:\/\/www.ecfr.gov\/on\/2018-07-19\/title-45\/subtitle-A\/subchapter-A\/part-46\" target=\"_blank\" rel=\"noreferrer noopener\">45 CFR 46<\/a>) governing research with human subjects, any research funded by the NSF is subject to additional rules from NSF.<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>.118 Determinations <\/strong><strong>&nbsp;<\/strong><\/h3>\n\n\n\n<p>For projects lacking definite plans for the use of human subjects, their data, or their specimens, the National Science Foundation (NSF) can accept a determination notice that establishes that the PI may conduct preliminary or conceptual work that does not involve human subjects.&nbsp;<\/p>\n\n\n\n<h3 class=\"wp-block-heading\"><strong>Additional Human Subjects Research Guidance from NSF&nbsp;<\/strong><\/h3>\n\n\n\n<p>NSF provides additional guidance on their site on \u201c<a href=\"https:\/\/new.nsf.gov\/policies\/pappg\/24-1\/ch-2-proposal-preparation#ch2E5\" target=\"_blank\" rel=\"noreferrer noopener\">Proposals Involving Human Subjects<\/a>\u201d, \u201c<a href=\"https:\/\/new.nsf.gov\/funding\/research-involving-human-subjects#timing-of-irb-review-e1d\" target=\"_blank\" rel=\"noreferrer noopener\">Timing of IRB Review<\/a>\u201d&nbsp; (opens in a new window), \u201c<a href=\"https:\/\/www.nsf.gov\/bfa\/dias\/policy\/hsfaqs.jsp\" target=\"_blank\" rel=\"noreferrer noopener\">Frequently Asked Questions<\/a>,\u201d and NSF\u2019s expectations for \u201c<a href=\"https:\/\/new.nsf.gov\/funding\/data-management-plan#nsfs-data-sharing-policy-1c8\" target=\"_blank\" rel=\"noreferrer noopener\">Preparing Your Data Management and Sharing Plan<\/a>.\u201d<\/p>\n\n\n      <\/p>\n  <\/details>\n\n\n<details class=\"wp-block-ncst-accordion-item\" name=\"jq84f5\"  >\n      <summary class=\"accordion-item__header\">\n        <span class=\"accordion-item__expansion-indicator\">\n          <span class=\"ncst-plus-minus-toggle\"><\/span>\n        <\/span>\n        <h2 class=\"accordion-item__label h6\">United States Department of Agriculture (USDA) &#8211; Including National Institute of Food and Agriculture (USDA-NIFA)<\/h2>\n      <\/summary>\n      <p>\n        \n\n<p>In addition to the Code of Federal Regulations (<a href=\"https:\/\/www.ecfr.gov\/on\/2018-07-19\/title-45\/subtitle-A\/subchapter-A\/part-46\" target=\"_blank\" rel=\"noreferrer noopener\">45 CFR 46<\/a>) governing research with human subjects, any research funded by USDA-NIFA is subject to additional rules from USDA-NIFA.<\/p>\n\n\n\n<ul class=\"wp-block-list\">\n<li>Be prepared to provide USDA-NIFA information about IRB approval before the award is granted.<\/li>\n\n\n\n<li>IRB Information to communicate in the USDA-NIFA application system can be found on their site in the section called \u201c<a href=\"https:\/\/www.nifa.usda.gov\/data\/nifa-reporting-system\/nrs-faq\">What does NIFA look for when reviewing IRB or IACUC Assurances<\/a>?\u201d<\/li>\n\n\n\n<li>As of December 2025, when accepting a USDA award for a human subjects research&nbsp;project, after IRB approval is granted but before any research procedures with human subjects are implemented,&nbsp;appropriate documentation must be provided to the USDA and subsequent written approval from the USDA is required. This approval does not need to be provided to the IRB but it must be available upon request. Please refer to section 10.13 in the&nbsp;<a href=\"https:\/\/www.usda.gov\/sites\/default\/files\/documents\/usda-general-terms-conditions-2025.pdf\">U.S. DEPARTMENT OF AGRICULTURE,&nbsp;General Terms and Conditions for Federal Awards&nbsp;<em>Effective December 31, 2025<\/em><\/a>.<\/li>\n<\/ul>\n\n\n      <\/p>\n  <\/details>\n\n\n    <\/div>\n  <\/div>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>Guidance Resources&nbsp;<\/strong><\/h2>\n\n\n\n<ul class=\"wp-block-list\">\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1_39nED1dWOUADfoPNKCWhx7Vf4vm2Jz-\/edit?usp=share_link&amp;ouid=118314250343958183913&amp;rtpof=true&amp;sd=true\" target=\"_blank\" rel=\"noreferrer noopener\">IRB Guidance Related to the Federal Transition<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/16IKH6EbO_rKxTyCcWH7bF0eBPwUMlL-u\/edit?usp=drive_link&amp;ouid=118314250343958183913&amp;rtpof=true&amp;sd=true\" target=\"_blank\" rel=\"noreferrer noopener\">Department of Defense (DoD) Research Unit Standard<\/a>&nbsp;<\/li>\n\n\n\n<li><a href=\"https:\/\/drive.google.com\/open?id=14UYmLz-VDywHk5lVRYXaPaxbxO3DK5sR\" target=\"_blank\" rel=\"noreferrer noopener\">Clinical Trials Unit Standard<\/a>&nbsp;<\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1-MvquGmC-pBi9S-aqfyQBtd0xnejWzo3\/edit?usp=sharing&amp;ouid=118314250343958183913&amp;rtpof=true&amp;sd=true\" target=\"_blank\" rel=\"noreferrer noopener\">Managing Conflicts of Interest Unit Standard<\/a>&nbsp;<\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1bho1Fpadb075_YNyd7cfMz0cUYODP-bL\/edit\" target=\"_blank\" rel=\"noreferrer noopener\">NIH Grants and the IRB<\/a>&nbsp;<\/li>\n\n\n\n<li><a href=\"https:\/\/docs.google.com\/document\/d\/1uOcIXWLkpWGXdb339dhvphxxQH4AUJw9\/edit\" target=\"_blank\" rel=\"noreferrer noopener\">Phased and Staged Research<\/a>&nbsp;<\/li>\n\n\n\n<li><a href=\"https:\/\/research.ncsu.edu\/administration\/compliance\/research-compliance\/irb\/irb-forms-and-templates\/request-a-letter-form\/\" target=\"_blank\" rel=\"noreferrer noopener\">Official Approval Letter Request<\/a>&nbsp;<\/li>\n\n\n\n<li><a href=\"https:\/\/research.ncsu.edu\/administration\/compliance\/research-compliance\/irb\/nhsr-determination\/\">Not Human Subjects Research Determinat<\/a><a href=\"https:\/\/research.ncsu.edu\/administration\/compliance\/research-compliance\/irb\/nhsr-determination\/\" target=\"_blank\" rel=\"noreferrer noopener\">i<\/a><a href=\"https:\/\/research.ncsu.edu\/administration\/compliance\/research-compliance\/irb\/nhsr-determination\/\">on Request<\/a><\/li>\n\n\n\n<li><a href=\"https:\/\/research.ncsu.edu\/administration\/compliance\/research-compliance\/irb\/determining-approval\/#jit\" target=\"_blank\" rel=\"noreferrer noopener\">Just-In-Time (NIH) and .118 Determination (NSF) Requests<\/a><\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>Federal Sponsors Guidance Resources&nbsp;<\/p>\n","protected":false},"author":16,"featured_media":0,"parent":338,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"source":"","ncst_custom_author":"","ncst_show_custom_author":false,"ncst_dynamicHeaderBlockName":"ncst\/default-header","ncst_dynamicHeaderData":"{\"pageIntro\":\"At NC State University, the IRB reviews unfunded, privately funded, and federally funded research in accordance with NC State University <a href=\\\"https:\/\/policies.ncsu.edu\/regulation\/reg-10-10-03\/\\\" target=\\\"_blank\\\" rel=\\\"noreferrer noopener\\\">Regulation 10.10.03<\/a>. Due to the nature of federally funded research, additional obligations may be required based on funding agency. Those obligations are detailed on this page.\u00a0\"}","ncst_content_audit_freq":"","ncst_content_audit_date":"","ncst_content_audit_display":false,"ncst_backToTopFlag":"","footnotes":""},"tags":[],"class_list":["post-13894","page","type-page","status-publish","hentry"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Federally Funded Research - Research Administration and Compliance<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/research.ncsu.edu\/administration\/compliance\/research-compliance\/irb\/federally-funded-research\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Federally Funded Research - Research Administration and Compliance\" \/>\n<meta property=\"og:description\" content=\"Federal Sponsors Guidance Resources&nbsp;\" \/>\n<meta property=\"og:url\" content=\"https:\/\/research.ncsu.edu\/administration\/compliance\/research-compliance\/irb\/federally-funded-research\/\" \/>\n<meta property=\"og:site_name\" content=\"Research Administration and Compliance\" \/>\n<meta property=\"article:modified_time\" content=\"2026-02-02T20:03:50+00:00\" \/>\n<meta name=\"twitter:card\" content=\"summary_large_image\" \/>\n<meta name=\"twitter:label1\" content=\"Est. reading time\" \/>\n\t<meta name=\"twitter:data1\" content=\"7 minutes\" \/>\n<script type=\"application\/ld+json\" class=\"yoast-schema-graph\">{\"@context\":\"https:\\\/\\\/schema.org\",\"@graph\":[{\"@type\":\"WebPage\",\"@id\":\"https:\\\/\\\/research.ncsu.edu\\\/administration\\\/compliance\\\/research-compliance\\\/irb\\\/federally-funded-research\\\/\",\"url\":\"https:\\\/\\\/research.ncsu.edu\\\/administration\\\/compliance\\\/research-compliance\\\/irb\\\/federally-funded-research\\\/\",\"name\":\"Federally Funded Research - 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