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<a href="/science-education/beams-challenge" class="link" data-drupal-link-system-path="node/143486"> <span>Lesson Plans</span>
|
||
</a>
|
||
|
||
</li>
|
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|
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|
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|
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|
||
<li class="usa-nav__submenu-item">
|
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|
||
|
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|
||
|
||
<a href="/science-education/meet-a-scientist" class="link" data-drupal-link-system-path="node/141721"> <span>Meet a Scientist</span>
|
||
</a>
|
||
|
||
</li>
|
||
|
||
|
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|
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|
||
<li class="usa-nav__submenu-item">
|
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|
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|
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|
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<a href="https://www.youtube.com/playlist?list=PLYH1eUq1QYrqrvA6HRRgKHcPsoJoJA6Kj" target="_blank" class="link"> <span>Featured Videos</span>
|
||
</a>
|
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|
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</li>
|
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|
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<li class="usa-nav__submenu-item">
|
||
|
||
|
||
|
||
|
||
<a href="/science-education/glossary" target="_self" class="link" data-drupal-link-system-path="science-education/glossary"> <span>Glossary</span>
|
||
</a>
|
||
|
||
</li>
|
||
|
||
|
||
</ul>
|
||
|
||
|
||
|
||
|
||
</div>
|
||
|
||
|
||
</div>
|
||
</div>
|
||
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</li>
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<li class="usa-nav__primary-item">
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<button type="button" class="usa-accordion__button usa-nav__link " aria-expanded="false" aria-controls="extended-mega-nav-section-5">
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<span>News & Events </span>
|
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</button>
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<div class="grid-row mm-container">
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<div class="desktop:grid-col flex-auto duplicated-parent">
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<div class="usa-nav__submenu-item">
|
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<span><a href="/news-events" target="_self" class="link" data-drupal-link-system-path="node/156671">News & Events</a> <span class="uswds-arrow-forward"></span></span>
|
||
</div>
|
||
</div>
|
||
</div>
|
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|
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<div class="grid-row mm-container">
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<div class="desktop:grid-col-4 submenu-list-container">
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<div class="usa-nav__submenu-item">
|
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<span target="_self" class="nolink"> <span class="usa-nav__submenu-heading">NEWS</span>
|
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</span>
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</div>
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<ul id="basic-nav-section-1" class="usa-nav__submenu-list">
|
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<li class="usa-nav__submenu-item">
|
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|
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|
||
|
||
|
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<a href="/news-events/newsroom" class="link" data-drupal-link-system-path="news-events/newsroom"> <span>Newsroom</span>
|
||
</a>
|
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|
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</li>
|
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|
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|
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<li class="usa-nav__submenu-item">
|
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|
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<a href="/news-events/press-releases" target="_self" class="link" data-drupal-link-system-path="news-events/press-releases"> <span>Press Releases</span>
|
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</a>
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</li>
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<li class="usa-nav__submenu-item">
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<a href="/news-events/science-highlights" target="_self" class="link" data-drupal-link-system-path="news-events/science-highlights"> <span>Science Highlights</span>
|
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<li class="usa-nav__submenu-item">
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<a href="/news-events/nibib-news" target="_self" class="link" data-drupal-link-system-path="news-events/nibib-news"> <span>NIBIB in the News</span>
|
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</a>
|
||
|
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|
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|
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|
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</ul>
|
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<div class="desktop:grid-col-4 submenu-list-container">
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<div class="usa-nav__submenu-item">
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<span class="nolink"> <span class="usa-nav__submenu-heading">EVENTS</span>
|
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</span>
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<ul id="basic-nav-section-2" class="usa-nav__submenu-list">
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|
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<a href="/news-events/meetings-events/upcoming-events" class="link" data-drupal-link-system-path="news-events/meetings-events/upcoming-events"> <span>Upcoming Events</span>
|
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</a>
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</li>
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<li class="usa-nav__submenu-item">
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|
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|
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<a href="/news-events/meetings-events/past-events" class="link" data-drupal-link-system-path="news-events/meetings-events/past-events"> <span>Past Events</span>
|
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</a>
|
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</li>
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<li class="usa-nav__submenu-item">
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<a href="/news-events/meetings-events/photo-galleries" class="link" data-drupal-link-system-path="news-events/meetings-events/photo-galleries"> <span>Event Photos</span>
|
||
</a>
|
||
|
||
</li>
|
||
|
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|
||
</ul>
|
||
|
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|
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|
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|
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</div>
|
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|
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|
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<div class="desktop:grid-col-4 submenu-list-container">
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<div class="usa-nav__submenu-item">
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<span target="_self" class="nolink"> <span class="usa-nav__submenu-heading">MEDIA RESOURCES</span>
|
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</span>
|
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</div>
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<ul id="basic-nav-section-3" class="usa-nav__submenu-list">
|
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<li class="usa-nav__submenu-item">
|
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|
||
|
||
|
||
|
||
<a href="/science-education/science-topics" target="_self" class="link" data-drupal-link-system-path="node/131271"> <span>Science Topics</span>
|
||
</a>
|
||
|
||
</li>
|
||
|
||
|
||
|
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|
||
<li class="usa-nav__submenu-item">
|
||
|
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|
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|
||
|
||
<a href="mailto:nibibpress@mail.nih.gov" target="_self" class="link"> <span>Contact Us</span>
|
||
</a>
|
||
|
||
</li>
|
||
|
||
|
||
</ul>
|
||
|
||
|
||
|
||
|
||
</div>
|
||
|
||
|
||
</div>
|
||
</div>
|
||
|
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|
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</li>
|
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|
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|
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|
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<li class="usa-nav__primary-item">
|
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|
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<button type="button" class="usa-accordion__button usa-nav__link " aria-expanded="false" aria-controls="extended-mega-nav-section-6">
|
||
<span>About NIBIB </span>
|
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</button>
|
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|
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|
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|
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|
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|
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<div id="extended-mega-nav-section-6" class="usa-nav__submenu usa-megamenu" hidden="">
|
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<div class="grid-row mm-container">
|
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<div class="desktop:grid-col flex-auto duplicated-parent">
|
||
<div class="usa-nav__submenu-item">
|
||
<span><a href="/about-nibib" target="_self" class="link" data-drupal-link-system-path="node/156676">About NIBIB</a> <span class="uswds-arrow-forward"></span></span>
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
<div class="grid-row mm-container">
|
||
|
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|
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|
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|
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<div class="desktop:grid-col-4 submenu-list-container">
|
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<div class="usa-nav__submenu-item">
|
||
<span target="_self" class="nolink"> <span class="usa-nav__submenu-heading">WHO WE ARE</span>
|
||
</span>
|
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</div>
|
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|
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|
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|
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|
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|
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|
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<ul id="basic-nav-section-1" class="usa-nav__submenu-list">
|
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<li class="usa-nav__submenu-item">
|
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|
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|
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|
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|
||
<a href="/about-nibib/mission" target="_self" class="link" data-drupal-link-system-path="node/79861"> <span>Mission & History</span>
|
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</a>
|
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|
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</li>
|
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|
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|
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|
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<li class="usa-nav__submenu-item">
|
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|
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|
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|
||
<a href="/about-nibib/directors-corner" target="_self" class="link" data-drupal-link-system-path="node/121791"> <span>Director's Corner</span>
|
||
</a>
|
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|
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</li>
|
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|
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|
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|
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|
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<li class="usa-nav__submenu-item">
|
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|
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|
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|
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|
||
<a href="/about-nibib/organizational-chart" target="_self" class="link" data-drupal-link-system-path="node/18836"> <span>Organization Chart</span>
|
||
</a>
|
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|
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</li>
|
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|
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|
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|
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|
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<li class="usa-nav__submenu-item">
|
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|
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|
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|
||
|
||
<a href="/about-nibib/advisory-council" target="_self" class="link" data-drupal-link-system-path="node/876"> <span>Advisory Council</span>
|
||
</a>
|
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|
||
</li>
|
||
|
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|
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|
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|
||
<li class="usa-nav__submenu-item">
|
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|
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|
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|
||
|
||
<a href="/about-nibib/careers-at-NIBIB" target="_self" class="link" data-drupal-link-system-path="node/131241"> <span>Jobs @ NIBIB</span>
|
||
</a>
|
||
|
||
</li>
|
||
|
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|
||
</ul>
|
||
|
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|
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|
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|
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</div>
|
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|
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|
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|
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|
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<div class="desktop:grid-col-4 submenu-list-container">
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<div class="usa-nav__submenu-item">
|
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<span target="_self" class="nolink"> <span class="usa-nav__submenu-heading">WHAT WE DO</span>
|
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</span>
|
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</div>
|
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|
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|
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<ul id="basic-nav-section-2" class="usa-nav__submenu-list">
|
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|
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<li class="usa-nav__submenu-item">
|
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|
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|
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|
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|
||
<a href="/about-nibib/strategic-plan" target="_self" class="link" data-drupal-link-system-path="node/11846"> <span>Strategic Plan</span>
|
||
</a>
|
||
|
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</li>
|
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|
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|
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|
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|
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<li class="usa-nav__submenu-item">
|
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|
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|
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|
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|
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<a href="/about-nibib/budget" target="_self" class="link" data-drupal-link-system-path="node/911"> <span>Budget</span>
|
||
</a>
|
||
|
||
</li>
|
||
|
||
|
||
</ul>
|
||
|
||
|
||
|
||
|
||
</div>
|
||
|
||
|
||
</div>
|
||
</div>
|
||
|
||
|
||
|
||
|
||
</li>
|
||
|
||
|
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</ul>
|
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|
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|
||
|
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|
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|
||
|
||
|
||
<div class="usa-nav__secondary">
|
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<div>
|
||
<section aria-label="search component" id="nibib-header-search" data-drupal-selector="search-block-form" role="search">
|
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<form id="search-block-form" accept-charset="UTF-8" class="usa-search usa-search--small" role="search" action="/searching" method="get">
|
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<label class="usa-sr-only" for="search-field-en-small">Search</label>
|
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<input aria-label="Search" class="usa-input" id="edit-keys" data-drupal-selector="edit-keys" data-original-title="Enter the terms you wish to search for." data-toggle="tooltip" type="search" name="q" value="" tabindex="-1"/>
|
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<button class="usa-button js-form-submit form-submit" name="search_btn" type="submit" value="Search" tabindex="-1">
|
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<img src="/themes/custom/nibib/assets/uswds/img/usa-icons-bg/search--white.svg" class="usa-search__submit-icon" alt="Search" />
|
||
</button>
|
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</form>
|
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</section>
|
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</div>
|
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|
||
|
||
|
||
<ul class="header-nav__secondary-list">
|
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<li class="header-nav__secondary-item">
|
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<a href="/es/nibib-en-espanol"> En Español
|
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</a>
|
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</li>
|
||
<li class="header-nav__secondary-item">
|
||
<a target="_blank" class="link-list-serve" href="https://public.govdelivery.com/accounts/USNIBIB/subscriber/edit?preferences=true#tab1"> Join LISTSERV
|
||
</a>
|
||
</li>
|
||
</ul>
|
||
|
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|
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|
||
|
||
|
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</div>
|
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</div>
|
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</nav>
|
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</header>
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|
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<main class="main-content usa-layout-docs usa-section " role="main" id="main-content">
|
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<div class="grid-container">
|
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<div class="grid-row breadcrumb-social-share-bar">
|
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<div class="tablet:grid-col-6 desktop:grid-col-8">
|
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<div>
|
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|
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<div id="block-breadcrumbs" class="block block-system block-system-breadcrumb-block">
|
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|
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<nav class="usa-breadcrumb--wrap" role="navigation" aria-label="breadcrumb">
|
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<ol class="usa-breadcrumb__list">
|
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<li class="usa-breadcrumb__list-item">
|
||
<a href="/" class="usa-breadcrumb__link"><span>Home</span></a>
|
||
</li>
|
||
<li class="usa-breadcrumb__list-item">
|
||
<a href="/programs/radx-tech-program" class="usa-breadcrumb__link"><span>RADx® Tech</span></a>
|
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</li>
|
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</ol>
|
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</nav>
|
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|
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</div>
|
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</div>
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|
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</div>
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<div class="tablet:grid-col-6 desktop:grid-col-4">
|
||
<div>
|
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|
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<div id="block-addtoanysharebuttons" class="block block-addtoany block-addtoany-block">
|
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|
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|
||
<span class="a2a_kit a2a_kit_size_32 addtoany_list" data-a2a-url="https://www.nibib.nih.gov/covid-19/radx-initiative-covid-19-testing/FAQs" data-a2a-title="RADx® Tech Program Frequently Asked Questions "><a class="a2a_button_email"><span class="a2a_svg a2a_s_a2a a2a_s_email a2a-box"><img src="/themes/custom/nibib/assets/img/email-a2a.svg" border="0" alt="Facebook" width="27" height="27"></span></a><a class="a2a_button_facebook"><span class="a2a_svg a2a_s_a2a a2a_s_facebook a2a-box"><img src="/themes/custom/nibib/assets/img/facebook-a2a.svg" border="0" alt="Facebook" width="27" height="27"></span></a><a class="a2a_button_linkedin"><span class="a2a_svg a2a_s_a2a a2a_s_linkedin a2a-box"><img src="/themes/custom/nibib/assets/img/linkedin-a2a.svg" border="0" alt="Facebook" width="27" height="27"></span></a><a class="a2a_button_twitter"><span class="a2a_svg a2a_s_a2a a2a_s_x a2a-box"><img src="/themes/custom/nibib/assets/img/x-a2a.svg" border="0" alt="Facebook" width="27" height="27"></span
|
||
</a><a class="a2a_button_whatsapp"><span class="a2a_svg a2a_s_a2a a2a_s_whatsapp a2a-box"><img src="/themes/custom/nibib/assets/img/whatsapp-a2a.svg" border="0" alt="Facebook" width="27" height="27"></span></a><a class="a2a_dd addtoany_share"><span class="a2a_svg a2a_s_a2a a2a_s_share a2a-box"><img src="/themes/custom/nibib/assets/img/share-a2a.svg" border="0" alt="Share" width="27" height="27"></span></a></span>
|
||
|
||
</div>
|
||
</div>
|
||
|
||
</div>
|
||
</div>
|
||
|
||
<div class="">
|
||
<div data-drupal-messages-fallback class="hidden"></div>
|
||
|
||
|
||
</div>
|
||
|
||
<div class="grid-row ">
|
||
|
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</div>
|
||
|
||
<div class="grid-row grid-gap">
|
||
|
||
<div class="usa-layout-docs__main desktop:grid-col-fill">
|
||
|
||
<div id="block-nibib-page-title" class="block--page-title-block">
|
||
|
||
|
||
<h1 class="margin-0 page-header">
|
||
<span>RADx® Tech Program Frequently Asked Questions </span>
|
||
</h1>
|
||
|
||
</div>
|
||
|
||
<div id="block-nibib-content" class="block block-system block-system-main-block">
|
||
|
||
|
||
|
||
|
||
<article data-history-node-id="117931" about="/covid-19/radx-initiative-covid-19-testing/FAQs" class="faqs node--faqs node--type-faqs">
|
||
|
||
|
||
|
||
|
||
<div class="content">
|
||
|
||
|
||
<div class="field field--name-body field--type-text-with-summary field--label-hidden field__item"></div>
|
||
|
||
<div id="faq-content-top-wrap">
|
||
<h3>Jump to questions about...</h3>
|
||
<div class="faq-quick-links">
|
||
</div>
|
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<hr>
|
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<ul class="usa-button-group">
|
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<li class="usa-button-group__item">
|
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<button class="faq-btn--open-all usa-button">Open All</button>
|
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</li>
|
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<li class="usa-button-group__item">
|
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<button class="faq-btn--close-all usa-button">Close All</button>
|
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</li>
|
||
</ul>
|
||
</div>
|
||
<div id="faq-content-bottom-wrap">
|
||
|
||
|
||
<div class="field field--name-field-content field--type-entity-reference-revisions field--label-hidden field__items">
|
||
<div class="field__item"> <div class="paragraph paragraph--type--faq-section paragraph--view-mode--default">
|
||
|
||
<div class="faq-section--wrapper">
|
||
<h3 class="faq-section-main-title">
|
||
|
||
|
||
|
||
<div class="field field--name-field-title field--type-string-long field--label-hidden field__item">RADx® Tech III Program - General FAQs</div>
|
||
|
||
|
||
</h3>
|
||
<div class="faq-section--content">
|
||
|
||
|
||
<div class="field field--name-field-content field--type-entity-reference-revisions field--label-hidden field__items">
|
||
<div class="field__item"> <div class="paragraph paragraph--type--faq-question-and-answer paragraph--view-mode--default">
|
||
|
||
<div class="usa-accordion usa-accordion--bordered">
|
||
<h4 class="usa-accordion__heading">
|
||
|
||
<button type="button" class="usa-accordion__button">
|
||
When can proposals be submitted?
|
||
|
||
</button>
|
||
</h4>
|
||
<div class="usa-accordion__content">
|
||
|
||
|
||
<div class="field field--name-field-answer field--type-text-long field--label-hidden field__item"><p>Submissions for these two solicitations is closed. </p>
|
||
<ul>
|
||
<li><a data-extlink href="https://www.poctrn.org/web/radx-accessible-tests/" rel="noopener nofollow" target="_blank">Solicitation to develop tests that are accessible to people with disabilities</a></li>
|
||
<li><a data-extlink href="https://www.poctrn.org/web/radx-tech-high-performance-tests" rel="noopener nofollow" target="_blank">Solicitation to develop tests with improved performance</a></li>
|
||
</ul>
|
||
<p> </p>
|
||
</div>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
</div>
|
||
<div class="field__item"> <div class="paragraph paragraph--type--faq-question-and-answer paragraph--view-mode--default">
|
||
|
||
<div class="usa-accordion usa-accordion--bordered">
|
||
<h4 class="usa-accordion__heading">
|
||
|
||
<button type="button" class="usa-accordion__button">
|
||
How will redesigned or new tests be developed?
|
||
|
||
</button>
|
||
</h4>
|
||
<div class="usa-accordion__content">
|
||
|
||
|
||
<div class="field field--name-field-answer field--type-text-long field--label-hidden field__item"><p>Projects will follow a staged, milestone-driven approach for development. Ideas will be rapidly reviewed and assessed for support. Projects that are funded will also receive in-kind resources to maximally accelerate progress. NIH will closely monitor progress of each project, and future support will be dependent upon achieving stated milestones.</p>
|
||
</div>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
</div>
|
||
<div class="field__item"> <div class="paragraph paragraph--type--faq-question-and-answer paragraph--view-mode--default">
|
||
|
||
<div class="usa-accordion usa-accordion--bordered">
|
||
<h4 class="usa-accordion__heading">
|
||
|
||
<button type="button" class="usa-accordion__button">
|
||
Is the goal of the program to facilitate authorization/clearance of improved COVID-19 tests by the U.S. Food and Drug Administration (FDA)?
|
||
|
||
</button>
|
||
</h4>
|
||
<div class="usa-accordion__content">
|
||
|
||
|
||
<div class="field field--name-field-answer field--type-text-long field--label-hidden field__item"><div aria-expanded="true" class="collapse in" id="purpose-2" style>
|
||
<p>Yes, the ultimate goal is to have new or redesigned tests meet the regulatory requirements to obtain Emergency Use Authorization (EUA) and/or 510(k) clearance through the U.S. Food and Drug Administration (FDA).</p>
|
||
</div>
|
||
</div>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
</div>
|
||
<div class="field__item"> <div class="paragraph paragraph--type--faq-question-and-answer paragraph--view-mode--default">
|
||
|
||
<div class="usa-accordion usa-accordion--bordered">
|
||
<h4 class="usa-accordion__heading">
|
||
|
||
<button type="button" class="usa-accordion__button">
|
||
Is obtaining FDA clearance necessary before the test can be deployed?
|
||
|
||
</button>
|
||
</h4>
|
||
<div class="usa-accordion__content">
|
||
|
||
|
||
<div class="field field--name-field-answer field--type-text-long field--label-hidden field__item"><p>Yes. FDA authorization/clearance is required for tests to be marketed in the U.S.</p>
|
||
</div>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
</div>
|
||
<div class="field__item"> <div class="paragraph paragraph--type--faq-question-and-answer paragraph--view-mode--default">
|
||
|
||
<div class="usa-accordion usa-accordion--bordered">
|
||
<h4 class="usa-accordion__heading">
|
||
|
||
<button type="button" class="usa-accordion__button">
|
||
How are confidentiality and intellectual property handled?
|
||
|
||
</button>
|
||
</h4>
|
||
<div class="usa-accordion__content">
|
||
|
||
|
||
<div class="field field--name-field-answer field--type-text-long field--label-hidden field__item"><p>The information contained within proposals is treated as confidential and all proposal reviewers sign a non-disclosure agreement when accessing the proposals. NIH retains the right to publicly share proposal summaries or abstracts; however, proprietary information will not be shared without the express written consent of the proposal submitter. </p>
|
||
<p>Proposals awarded under this solicitation are required to comply with all of the <a href="https://grants.nih.gov/grants/policy/awardconditions.htm">NIH Standard Award Terms and Conditions</a>. Specifically, information on the management of intellectual property can be found in <a href="https://grants.nih.gov/grants/policy/nihgps/HTML5/section_8/8.2.4_inventions_and_patents.htm">Section 8.2.4 </a>of the NIH Grants Policy Statement. In brief, the Bayh-Dole Act of 1980 (Public Law 96-517; 35 U.S.C. 200-212; Executive Order 12591; 37 C.F.R. 401 et al; updated April 14, 2018.) is applicable to RADx Tech funding recipients and provides incentives to promote the utilization of inventions conceived or reduced to practice in the performance of federally supported research and development. The Bayh-Dole Act applies to all NIH research and development funding granted to for-profit organizations regardless of size and all non-profit entities.</p>
|
||
</div>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
</div>
|
||
<div class="field__item"> <div class="paragraph paragraph--type--faq-question-and-answer paragraph--view-mode--default">
|
||
|
||
<div class="usa-accordion usa-accordion--bordered">
|
||
<h4 class="usa-accordion__heading">
|
||
|
||
<button type="button" class="usa-accordion__button">
|
||
Can applicants from outside the U.S. apply?
|
||
|
||
</button>
|
||
</h4>
|
||
<div class="usa-accordion__content">
|
||
|
||
|
||
<div class="field field--name-field-answer field--type-text-long field--label-hidden field__item"><p>Yes. NIH encourages all innovators to submit their promising ideas on how to improve tests.</p>
|
||
</div>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
</div>
|
||
<div class="field__item"> <div class="paragraph paragraph--type--faq-question-and-answer paragraph--view-mode--default">
|
||
|
||
<div class="usa-accordion usa-accordion--bordered">
|
||
<h4 class="usa-accordion__heading">
|
||
|
||
<button type="button" class="usa-accordion__button">
|
||
Can diagnostic test components be manufactured outside the U.S.?
|
||
|
||
</button>
|
||
</h4>
|
||
<div class="usa-accordion__content">
|
||
|
||
|
||
<div class="field field--name-field-answer field--type-text-long field--label-hidden field__item"><p>At this time there are no requirements that test supplies and components be manufactured exclusively within the U.S.</p>
|
||
</div>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
</div>
|
||
<div class="field__item"> <div class="paragraph paragraph--type--faq-question-and-answer paragraph--view-mode--default">
|
||
|
||
<div class="usa-accordion usa-accordion--bordered">
|
||
<h4 class="usa-accordion__heading">
|
||
|
||
<button type="button" class="usa-accordion__button">
|
||
Do plans for marketing have to include the U.S.?
|
||
|
||
</button>
|
||
</h4>
|
||
<div class="usa-accordion__content">
|
||
|
||
|
||
<div class="field field--name-field-answer field--type-text-long field--label-hidden field__item"><p>Yes, project teams must plan to market and deploy the test within the U.S.</p>
|
||
</div>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
</div>
|
||
<div class="field__item"> <div class="paragraph paragraph--type--faq-question-and-answer paragraph--view-mode--default">
|
||
|
||
<div class="usa-accordion usa-accordion--bordered">
|
||
<h4 class="usa-accordion__heading">
|
||
|
||
<button type="button" class="usa-accordion__button">
|
||
Does my device have to be a COVID-19 test? Can it be a component/reader etc.?
|
||
|
||
</button>
|
||
</h4>
|
||
<div class="usa-accordion__content">
|
||
|
||
|
||
<div class="field field--name-field-answer field--type-text-long field--label-hidden field__item"><p>There is no provision for components in this solicitation. If you have a component product that you’d like to develop we might suggest partnering with an assay developer and applying as a team.</p>
|
||
</div>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
</div>
|
||
<div class="field__item"> <div class="paragraph paragraph--type--faq-question-and-answer paragraph--view-mode--default">
|
||
|
||
<div class="usa-accordion usa-accordion--bordered">
|
||
<h4 class="usa-accordion__heading">
|
||
|
||
<button type="button" class="usa-accordion__button">
|
||
Can companies developing a multiplex test apply?
|
||
|
||
</button>
|
||
</h4>
|
||
<div class="usa-accordion__content">
|
||
|
||
|
||
<div class="field field--name-field-answer field--type-text-long field--label-hidden field__item"><p>Yes, but the test must detect COVID-19 and meet the other submission criteria.</p>
|
||
</div>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
</div>
|
||
<div class="field__item"> <div class="paragraph paragraph--type--faq-question-and-answer paragraph--view-mode--default">
|
||
|
||
<div class="usa-accordion usa-accordion--bordered">
|
||
<h4 class="usa-accordion__heading">
|
||
|
||
<button type="button" class="usa-accordion__button">
|
||
Will funding be supported for clinical testing/trials?
|
||
|
||
</button>
|
||
</h4>
|
||
<div class="usa-accordion__content">
|
||
|
||
|
||
<div class="field field--name-field-answer field--type-text-long field--label-hidden field__item"><p>Yes, limited funding for clinical testing/trials will be available as part of the work packages developed by projects that reach this stage. For example, funds could be used to support a small clinical trial to support an EUA submission to the FDA. </p>
|
||
<p>Larger trials required for a 510(k)-clearance submission are expected to be supported by the applicants themselves.</p>
|
||
</div>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
</div>
|
||
<div class="field__item"> <div class="paragraph paragraph--type--faq-question-and-answer paragraph--view-mode--default">
|
||
|
||
<div class="usa-accordion usa-accordion--bordered">
|
||
<h4 class="usa-accordion__heading">
|
||
|
||
<button type="button" class="usa-accordion__button">
|
||
Does an applicant have to be a current RADx company to apply?
|
||
|
||
</button>
|
||
</h4>
|
||
<div class="usa-accordion__content">
|
||
|
||
|
||
<div class="field field--name-field-answer field--type-text-long field--label-hidden field__item"><p>No, this is an open solicitation.</p>
|
||
</div>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
</div>
|
||
<div class="field__item"> <div class="paragraph paragraph--type--faq-question-and-answer paragraph--view-mode--default">
|
||
|
||
<div class="usa-accordion usa-accordion--bordered">
|
||
<h4 class="usa-accordion__heading">
|
||
|
||
<button type="button" class="usa-accordion__button">
|
||
If my company is already in the RADx portfolio, can I still apply?
|
||
|
||
</button>
|
||
</h4>
|
||
<div class="usa-accordion__content">
|
||
|
||
|
||
<div class="field field--name-field-answer field--type-text-long field--label-hidden field__item"><p>Yes, current and past RADx awarded companies may apply to the new solicitations. </p>
|
||
</div>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
</div>
|
||
<div class="field__item"> <div class="paragraph paragraph--type--faq-question-and-answer paragraph--view-mode--default">
|
||
|
||
<div class="usa-accordion usa-accordion--bordered">
|
||
<h4 class="usa-accordion__heading">
|
||
|
||
<button type="button" class="usa-accordion__button">
|
||
Can companies apply to both the RADx High Performance Test program and RADx Tech Accessible Test program?
|
||
|
||
</button>
|
||
</h4>
|
||
<div class="usa-accordion__content">
|
||
|
||
|
||
<div class="field field--name-field-answer field--type-text-long field--label-hidden field__item"><p>Yes, companies can submit a separate application to each program. Solutions should address defined unmet needs for each solicitation.</p>
|
||
</div>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
</div>
|
||
<div class="field__item"> <div class="paragraph paragraph--type--faq-section paragraph--view-mode--default">
|
||
|
||
<div class="faq-section--wrapper">
|
||
<h3 class="faq-section-main-title">
|
||
|
||
|
||
|
||
<div class="field field--name-field-title field--type-string-long field--label-hidden field__item">FAQs specific to solicitation for accessible tests</div>
|
||
|
||
|
||
</h3>
|
||
<div class="faq-section--content">
|
||
|
||
|
||
<div class="field field--name-field-content field--type-entity-reference-revisions field--label-hidden field__items">
|
||
<div class="field__item"> <div class="paragraph paragraph--type--faq-question-and-answer paragraph--view-mode--default">
|
||
|
||
<div class="usa-accordion usa-accordion--bordered">
|
||
<h4 class="usa-accordion__heading">
|
||
|
||
<button type="button" class="usa-accordion__button">
|
||
What is the RADx Accessible Tests Program?
|
||
|
||
</button>
|
||
</h4>
|
||
<div class="usa-accordion__content">
|
||
|
||
|
||
<div class="field field--name-field-answer field--type-text-long field--label-hidden field__item"><p>The RADx Accessible Tests program was established to accelerate the development of over-the-counter (OTC) COVID-19 diagnostic technologies that can be used independently by people with disabilities (e.g., blindness, low vision, fine motor skill difficulties, and aging-related disabilities).</p>
|
||
</div>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
</div>
|
||
<div class="field__item"> <div class="paragraph paragraph--type--faq-question-and-answer paragraph--view-mode--default">
|
||
|
||
<div class="usa-accordion usa-accordion--bordered">
|
||
<h4 class="usa-accordion__heading">
|
||
|
||
<button type="button" class="usa-accordion__button">
|
||
What are the unmet needs?
|
||
|
||
</button>
|
||
</h4>
|
||
<div class="usa-accordion__content">
|
||
|
||
|
||
<div class="field field--name-field-answer field--type-text-long field--label-hidden field__item"><div aria-expanded="true" class="collapse in" id="question-2" style>
|
||
<p>Throughout the pandemic, there has been an increased focus on the development and production of COVID-19 diagnostic tests for at-home use to help combat the spread of the virus. However, home users can have a large range of physical and sensory challenges that should be considered in the test design. Currently, most tests on the market make heavy use of visual information with no alternative modalities such as auditory or haptic feedback available, inhibiting independent use by people with no or low vision. Many tests use small components, require precise manipulations, and/or require significant force for one or more steps, creating additional challenges for users with fine motor control impairments or reduced hand strength. As a result, independent use of OTC tests for people with disabilities can be challenging or impossible. New or redesigned OTC tests to support accessible use are needed. Please find additional resources <a href="/covid-19/radx-tech-program/listening-session/agenda">here</a>.</p>
|
||
</div>
|
||
</div>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
</div>
|
||
<div class="field__item"> <div class="paragraph paragraph--type--faq-question-and-answer paragraph--view-mode--default">
|
||
|
||
<div class="usa-accordion usa-accordion--bordered">
|
||
<h4 class="usa-accordion__heading">
|
||
|
||
<button type="button" class="usa-accordion__button">
|
||
What would be an example of a proposal that meets accessibility needs for the RADx Tech Accessible Test program?
|
||
|
||
</button>
|
||
</h4>
|
||
<div class="usa-accordion__content">
|
||
|
||
|
||
<div class="field field--name-field-answer field--type-text-long field--label-hidden field__item"><p>A product that incorporates design elements and functionality that allows greater usability for individuals with disabilities including but not limited to blind/low vision, fine motor skill impairments, and aging populations. </p>
|
||
<p>Applications that highlight a product that does not rely on smart technology (i.e., smart phones, computers, expensive readers) are strongly encouraged as many users do not have smart technology or cannot use smart technology. Applications that highlight a product that increases accessibility across various disabilities are also encouraged.</p>
|
||
</div>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
</div>
|
||
<div class="field__item"> <div class="paragraph paragraph--type--faq-question-and-answer paragraph--view-mode--default">
|
||
|
||
<div class="usa-accordion usa-accordion--bordered">
|
||
<h4 class="usa-accordion__heading">
|
||
|
||
<button type="button" class="usa-accordion__button">
|
||
Are these tests intended to be produced only for people with disabilities?
|
||
|
||
</button>
|
||
</h4>
|
||
<div class="usa-accordion__content">
|
||
|
||
|
||
<div class="field field--name-field-answer field--type-text-long field--label-hidden field__item"><p>New and redesigned products should be easier to use for everyone. While the objective is to create tests that are accessible to people with disabilities, these design improvements will also benefit the non-disabled population using them. For example, a test with fewer, easier-to-manipulate parts, or simplified instructions with larger print could improve the test experience for all users.</p>
|
||
</div>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
</div>
|
||
<div class="field__item"> <div class="paragraph paragraph--type--faq-question-and-answer paragraph--view-mode--default">
|
||
|
||
<div class="usa-accordion usa-accordion--bordered">
|
||
<h4 class="usa-accordion__heading">
|
||
|
||
<button type="button" class="usa-accordion__button">
|
||
How much will the new or redesigned OTC tests cost?
|
||
|
||
</button>
|
||
</h4>
|
||
<div class="usa-accordion__content">
|
||
|
||
|
||
<div class="field field--name-field-answer field--type-text-long field--label-hidden field__item"><p>Test costs should be competitive with similar products currently on the market. Applications must address materials and manufacturing costs, along with commercialization plans.</p>
|
||
</div>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
|
||
</div>
|
||
</div>
|
||
</div>
|
||
|
||
</div>
|
||
</div>
|
||
</article>
|
||
|
||
|
||
</div>
|
||
|
||
</div>
|
||
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