Public Availability of Advisory Committee Members' Financial Interest Information and Waivers

<!DOCTYPE html> <html lang="en" dir="ltr" prefix="og: https://ogp.me/ns#"> <head> <meta charset="utf-8" /> <script async src="https://www.googletagmanager.com/gtag/js?id=G-273DTKB5QW"></script> <meta name="description" content="Public Availability of Advisory Committee Members' Financial Interest Information and Waivers: Guidance for the Public, FDA Advisory Committee Members, and FDA Staff - Final Guidance, March 2014" /> <meta name="dcterms.title" content="Public Availability of Advisory Committee Members' Financial Interest Information and Waivers" /> <meta name="dcterms.creator" content="Office of the Commissioner" /> <meta name="dcterms.description" content="Public Availability of Advisory Committee Members' Financial Interest Information and Waivers: Guidance for the Public, FDA Advisory Committee Members, and FDA Staff - Final Guidance, March 2014" /> <meta name="dcterms.publisher" content="FDA" /> <meta name="dcterms.contributor" content="Office of the Commissioner" /> <meta property="og:site_name" content="U.S. Food and Drug Administration" /> <meta property="og:type" content="Article" /> <meta property="og:url" content="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/public-availability-advisory-committee-members-financial-interest-information-and-waivers" /> <meta property="og:title" content="Public Availability of Committee Members' Financial Interest Info" /> <meta property="og:description" content="Public Availability of Adv. Comm. Members' Financial Interest Information and Waivers: Guidance for the Public, FDA Advisory Committee Members, and FDA Staff" /> <meta property="og:updated_time" content="Tue, 03/27/2018 - 06:15" /> <meta property="article:publisher" content="FDA" /> <meta property="article:published_time" content="Sat, 04/20/2019 - 23:10" /> <meta property="article:modified_time" content="Tue, 03/27/2018 - 06:15" /> <meta name="google-site-verification" content="tWxlDhm4ANdksJZPj7TBmHgNoMqZCnecPp0Aa2vC9XA" /> <meta name="twitter:card" content="summary_large_image" /> <meta name="twitter:site" content="@US_FDA" /> <meta property="twitter:description" content="Public Availability of Adv. Comm. Members' Financial Interest Information and Waivers: Guidance for the Public, FDA Advisory Committee Members, and FDA Staff" /> <meta name="twitter:title" content="Public Availability of Committee Members' Financial Interest Info" /> <meta name="twitter:creator" content="@US_FDA" /> <meta name="MobileOptimized" content="width" /> <meta name="HandheldFriendly" content="true" /> <meta name="viewport" content="width=device-width, initial-scale=1.0" /> <script type="application/ld+json">{ "@context": "https://schema.org", "@graph": [ { "@type": "Article", "headline": "Public Availability of Advisory Committee Members\u0027 Financial Interest Information and Waivers", "name": "Public Availability of Advisory Committee Members\u0027 Financial Interest Information and Waivers", "description": "Public Availability of Advisory Committee Members\u0027 Financial Interest Information and Waivers: Guidance for the Public, FDA Advisory Committee Members, and FDA Staff - Final Guidance, March 2014", "datePublished": "Sat, 04/20/2019 - 23:10", "dateModified": "Tue, 03/27/2018 - 06:15", "author": { "@type": "Organization", "name": "Office of the Commissioner" }, "publisher": { "@type": "Organization", "name": "FDA" } } ] }</script> <meta property="og:image" content="https://www.fda.gov/themes/custom/preview/img/FDA-Social-Graphic.png" /> <meta name="twitter:image" content="https://www.fda.gov/themes/custom/preview/img/FDA-Social-Graphic.png" /> <link rel="icon" href="/themes/custom/preview/favicon.ico" type="image/vnd.microsoft.icon" /> <link rel="alternate" hreflang="en" href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/public-availability-advisory-committee-members-financial-interest-information-and-waivers" /> <link rel="canonical" href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/public-availability-advisory-committee-members-financial-interest-information-and-waivers" /> <link rel="shortlink" href="https://www.fda.gov/node/365165" /> <script src="/files/google_tag/production/google_tag.script.js?smgeuw" defer></script> <title>Public Availability of Advisory Committee Members' Financial Interest Information and Waivers | FDA</title> <link rel="stylesheet" media="all" href="/files/css/css_nIAEFYPN7y_O0y9dA__6_ZBSGy8omYOK6rvMeZ1warY.css?delta=0&language=en&theme=preview&include=eJxljlEOwjAMQy_UUX6QuE2VtVmpaOuqCUPj9DAQA8FP5NiS_SZUpSsLCtvpo3cmAjGzo0p50eTF_hpGFlEudiRh0zrPia82ZoyUB9Elpxr_bN9TUzEjoKKdmm1omLmbKZDzZw5J0R3XE1XPhauKJe_RQ0J1irgCyAldPQKbtVrs8-4KwiXzqwel5bQ2vDJ32B-_TDM91iuUxW5qA_WdbgvHD3mg9tx6_9v6sIHdAfkmf6A" /> <link rel="stylesheet" media="all" href="/files/css/css_xLeUZALg1CD0YmiSIzZnqkwKfNF_g3TkAjkxBt_uccA.css?delta=1&language=en&theme=preview&include=eJxljlEOwjAMQy_UUX6QuE2VtVmpaOuqCUPj9DAQA8FP5NiS_SZUpSsLCtvpo3cmAjGzo0p50eTF_hpGFlEudiRh0zrPia82ZoyUB9Elpxr_bN9TUzEjoKKdmm1omLmbKZDzZw5J0R3XE1XPhauKJe_RQ0J1irgCyAldPQKbtVrs8-4KwiXzqwel5bQ2vDJ32B-_TDM91iuUxW5qA_WdbgvHD3mg9tx6_9v6sIHdAfkmf6A" /> <script src="https://script.crazyegg.com/pages/scripts/0024/3700.js" async></script> <script src="https://dap.digitalgov.gov/Universal-Federated-Analytics-Min.js?agency=HHS&subagency=FDA&sdor=fda.gov&dclink=true" language="javascript" id="_fed_an_ua_tag"></script> <script>window.dataLayer = window.dataLayer || [];function gtag(){dataLayer.push(arguments)};gtag("js", new Date());gtag("set", "developer_id.dMDhkMT", true);gtag("config", "G-273DTKB5QW", {"groups":"default","page_placeholder":"PLACEHOLDER_page_location","allow_ad_personalization_signals":false});</script> </head> <body class="role-anonymous path-node page-node-type-guidance has-glyphicons"> <div id="quicklinks" class="sr-only"> <ul> <li><a href="#main-content" class="sr-only sr-only-focusable" tabindex="1">Skip to main content</a></li> <li><a href="#search-form" class="sr-only sr-only-focusable" tabindex="1">Skip to FDA Search</a></li> <li><a href="#section-nav" class="sr-only sr-only-focusable" tabindex="1">Skip to in this section menu</a></li> <li><a href="#footer-heading" class="sr-only sr-only-focusable" tabindex="1">Skip to footer links</a></li> </ul> </div> <noscript><iframe src="https://www.googletagmanager.com/ns.html?id=GTM-M95XGZW" height="0" width="0" style="display:none;visibility:hidden"></iframe></noscript> <div class="dialog-off-canvas-main-canvas" data-off-canvas-main-canvas> <div class="main-container container-fluid"> <div class="row"> <header class="lcds-header container-fluid" role="heading" aria-level="1"> <div class="row us-masthead"> <div class="usa-banner col-xs-12"> <img class="usa-banner__us-flag" src="/themes/custom/preview/assets/images/US_Flag.png" alt="U.S. flag" /> <span>An official website of the United States government</span> <a id="USMenuButton" class="collapsed" data-toggle="collapse" data-target="#USABannerMenu" aria-controls="USABannerMenu">Here’s how you know <span class="toggle-indicator"> </span></a> <div class="col-xs-12 collapse usa-banner__menu" id="USABannerMenu" aria-labelledby="USMenuButton"> <div id="gov-banner" class="row usa-banner-content usa-grid usa-accordion-content" aria-hidden="true"> <div class="col-xs-12 col-sm-6 col-md-3"> <img class="usa-banner-icon usa-media_block-img" src="/themes/custom/preview/assets/images/icon-dot-gov.svg" alt="Dot gov" style="width:3em;"> <div class="usa-media_block-body"> <p><strong>The .gov means it’s official.</strong><br>Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.</p> </div> </div> <div class="col-xs-12 col-sm-6 col-md-3"> <img class="usa-banner-icon usa-media_block-img" src="/themes/custom/preview/assets/images/icon-https.svg" alt="SSL" style="width:3em;"> <div class="usa-media_block-body"> <p><strong>The site is secure.</strong><br> The <strong>https://</strong> ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.</p> </div> </div> </div> </div> </div> </div> <div class="alert alert-warning margin-left-neg-2 margin-right-neg-2 margin-top-3 margin-bottom-1"> <p>On Oct. 1, 2024, the FDA began implementing a <a href="/about-fda/fda-organization/fda-modernization-efforts-establishing-unified-human-foods-program-new-model-field-operations-and" title="FDA Modernization Efforts for Establishing a Unified Human Foods Program, New Model for Field Operations and More">reorganization</a> impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.</p> </div> <div class="row fda-masthead"> <div class="col-xs-4 col-md-8"> <a href="/" title="FDA Homepage"> <h1 class="fda-masthead__fda-logo">U.S. Food and Drug Administration</h1> </a> </div> <div class="col-xs-8 col-md-4"> <ul class='fda-masthead__item-list'> <li><a title="" id="btn-search" class="btn btn-default btn-sm fda-masthead__btn-search"> <span class="fa fa-search" aria-hidden="true"> </span> <span class="fda-masthead__btn-label">Search</span> </a></li> <li><a id="menu-btn" class="btn btn-default btn-sm fda-masthead__btn-menu collapsed" href="#primary-nav" data-toggle="collapse" aria-expanded="true"> <span class="fa fa-bars" aria-hidden="true"> </span> <span class='fda-masthead__btn-label'>Menu</span> </a></li> </ul> </div> <form class="fda-masthead__search sr-only" role="search" action="/search" method="GET" name="searchForm" id="search-form" accept-charset="UTF-8" > <div class="search-popover" id="search-popover"> <div class="input-group pull-right" id="search-group"> <label class="sr-only" for="search-query">Search FDA</label> <input class="form-control search-input" id="search-query" name="s" aria-autocomplete="list" aria-haspopup="true" title="Enter the terms you wish to search for." placeholder="Search FDA" type="text" /> <span class="input-group-btn" id="input-group-btn"> <button type="submit" class="btn btn-danger search-btn" id="search-btn" title="Search"><span class="fa fa-search" aria-hidden="true"><span class="sr-only">Submit search</span></span></button> </span> </div> </div> </form> </div> <nav id="primary-nav" class="lcds-primary-nav row collapse"> <div class="col-md-5 col-lg-4"> <section class="lcds-primary-nav__group lcds-primary-nav__group--bordered"> <h2 class="lcds-primary-nav__group-heading">Featured</h2> <ul class="lcds-primary-nav__list lcds-primary-nav__list--featured"> <li class="lcds-primary-nav__list-item"><a href="https://www.safetyreporting.hhs.gov/smarthub#/" title="Report a Problem with an FDA Regulated Product">Report a Product Problem</a></li> <li class="lcds-primary-nav__list-item"><a href="/about-fda/contact-fda">Contact FDA</a></li> <li class="lcds-primary-nav__list-item"><a href="/regulatory-information/search-fda-guidance-documents">FDA Guidance Documents</a></li> <li class="lcds-primary-nav__list-item"><a href="/safety/recalls-market-withdrawals-safety-alerts">Recalls, Market Withdrawals and Safety Alerts</a></li> <li class="lcds-primary-nav__list-item"><a href="/news-events/newsroom/press-announcements">Press Announcements</a></li> <li class="lcds-primary-nav__list-item"><a href="/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters">Warning Letters</a></li> <li class="lcds-primary-nav__list-item"><a href="/advisory-committees">Advisory Committees</a></li> <li class="lcds-primary-nav__list-item"><a href="/fda-en-espanol">En Espa&#241ol</a></li> </ul> </section> </div> <div class="col-md-7 col-lg-8"> <section class="lcds-primary-nav__group lcds-primary-nav__group--bordered"> <h2 class="lcds-primary-nav__group-heading">Products</h2> <ul class="lcds-primary-nav__list"> <li class="lcds-primary-nav__list-item"><a href="/food">Food</a></li> <li class="lcds-primary-nav__list-item"><a href="/drugs">Drugs</a></li> <li class="lcds-primary-nav__list-item"><a href="/medical-devices">Medical Devices</a></li> <li class="lcds-primary-nav__list-item"><a href="/radiation-emitting-products">Radiation-Emitting Products</a></li> <li class="lcds-primary-nav__list-item"><a href="/vaccines-blood-biologics">Vaccines, Blood, and Biologics</a></li> <li class="lcds-primary-nav__list-item"><a href="/animal-veterinary">Animal and Veterinary</a></li> <li class="lcds-primary-nav__list-item"><a href="/cosmetics">Cosmetics</a></li> <li class="lcds-primary-nav__list-item"><a href="/tobacco-products">Tobacco Products</a></li> </ul> </section> <section class="lcds-primary-nav__group lcds-primary-nav__group--bordered"> <h2 class="lcds-primary-nav__group-heading">Topics</h2> <ul class="lcds-primary-nav__list"> <li class="lcds-primary-nav__list-item"><a href="/about-fda">About FDA</a></li> <li class="lcds-primary-nav__list-item"><a href="/combination-products">Combination Products</a></li> <li class="lcds-primary-nav__list-item"><a href="/regulatory-information">Regulatory Information</a></li> <li class="lcds-primary-nav__list-item"><a href="/safety">Safety</a></li> <li class="lcds-primary-nav__list-item"><a href="/emergency-preparedness-and-response">Emergency Preparedness</a></li> <li class="lcds-primary-nav__list-item"><a href="/international-programs">International Programs</a></li> <li class="lcds-primary-nav__list-item"><a href="/news-events">News and Events</a></li> <li class="lcds-primary-nav__list-item"><a href="/training-and-continuing-education">Training and Continuing Education</a></li> <li class="lcds-primary-nav__list-item"><a href="/inspections-compliance-enforcement-and-criminal-investigations">Inspections and Compliance</a></li> <li class="lcds-primary-nav__list-item"><a href="/science-research">Science and Research</a></li> </ul> </section> <section class="lcds-primary-nav__group lcds-primary-nav__group--bordered"> <h2 class="lcds-primary-nav__group-heading">Information For</h2> <ul class="lcds-primary-nav__list"> <li class="lcds-primary-nav__list-item"><a href="/consumers">Consumers</a></li> <li class="lcds-primary-nav__list-item"><a href="/patients">Patients</a></li> <li class="lcds-primary-nav__list-item"><a href="/industry">Industry</a></li> <li class="lcds-primary-nav__list-item"><a href="/health-professionals">Health Professionals</a></li> <li class="lcds-primary-nav__list-item"><a href="/federal-state-local-tribal-and-territorial-officials">Federal, State and Local Officials</a></li> </ul> </section> </div> </nav> </header> <div class="col-xs-12"> <div data-drupal-messages-fallback class="hidden"></div> </div> <section id="block-entityviewcontent" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <a class="lcds-button--expandable collapsed hidden-md hidden-lg" data-toggle="collapse" href="#section-nav" >In this section<span class="visible-sm-inline-block">: Search for FDA Guidance Documents </span> </a> <nav id="section-nav" class="lcds-card lcds-section-nav lcds-section-nav hidden-md hidden-lg collapse"> <ul class="lcds-section-nav__list"> <li> <a href="/regulatory-information/search-fda-guidance-documents" title="Search for FDA Guidance Documents" class="lcds-section-nav__section-link lcds-section-nav__link lcds-section-nav__parent-link visible-xs-block visible-sm-block"> Search for FDA Guidance Documents </a> <div class="views-element-container form-group"><div class="view view-in-this-section view-id-in_this_section view-display-id-block_5 js-view-dom-id-4c7bebca2738b0efca1d98c35fdbb6f37681cd3955b7f1cbcd4969d53c81bc83"> <div> <ul class="lcds-section-nav__section-link__active lcds-section-nav__list"> <li><a href="/regulatory-information/search-fda-guidance-documents/search-general-and-cross-cutting-topics-guidance-documents" class="lcds-section-nav__link">Search General and Cross-Cutting Topics Guidance Documents</a></li> <li><a href="/regulatory-information/search-fda-guidance-documents/advisory-committee-guidance-documents" class="lcds-section-nav__link">Advisory Committee Guidance Documents</a></li> <li><a href="/regulatory-information/search-fda-guidance-documents/import-and-export-guidance-documents" class="lcds-section-nav__link">Import and Export Guidance Documents</a></li> <li><a href="/regulatory-information/search-fda-guidance-documents/cross-cutting-guidance-documents" class="lcds-section-nav__link">Cross-cutting Guidance Documents</a></li> </ul> </div> </div> </div> <div class="views-element-container form-group"><div class="view view-in-this-section-sub view-id-in_this_section_sub view-display-id-block_2 js-view-dom-id-3dd553bbe72cf54d50db0f722e0fc48d8da30bb3bd7da13b41b13915ba022933"> <div class="view-content"> <div> <ul class="lcds-section-nav__list"> <li><a href="/regulatory-information/search-fda-guidance-documents/guidances" class="lcds-section-nav__section-link lcds-section-nav__link">Guidances</a></li> </ul> </div> </div> </div> </div> </li> </ul> </nav> </section> <section id="block-entityviewcontent-15" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <ol class="lcds-breadcrumb visible-md visible-lg"> <li > <a href="/">Home</a> </li> <li > <a href="/regulatory-information">Regulatory Information</a> </li> <li > <a href="/regulatory-information/search-fda-guidance-documents">Search for FDA Guidance Documents</a> </li> <li > <a class="current-link">Public Availability of Advisory Committee Members' Financial Interest Information and Waivers</a> </li> </ol> <ol class="lcds-breadcrumb visible-sm visible-xs"> <li> <a href="/regulatory-information/search-fda-guidance-documents" title="Search for FDA Guidance Documents"> Search for FDA Guidance Documents </a> </li> </ol> </section> <main> <article id="main-content" class="article main-content container-fluid" role="article"> <header class="row content-header" role="heading" aria-level="1"> <section id="block-entityviewcontent-11" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="col-sm-12 col-md-8 col-md-offset-2"> <p class="content-type-label text-center">GUIDANCE DOCUMENT</p> <h1 class="text-center content-title">Public Availability of Advisory Committee Members' Financial Interest Information and Waivers <span class="article-subtitle text-center">Guidance for the Public, FDA Advisory Committee Members, and FDA Staff</span> <span class="font-family-sans">March 2014</span> </h1> <div class="lcds-toolbar text-center"> <a class="btn btn-primary" href="/media/83188/download">Download the Final Guidance Document</a> </div> <div class="lcds-statusbar text-center"> <span class="label label-default">Final</span> </div> <div class="lcds-toolbar lcds-toolbar--social"> <ul class="lcds-share lcds-share--default"> <li class="lcds-share__item"> <a href="https://www.facebook.com/sharer/sharer.php?u=https://www.fda.gov%2Fregulatory-information%2Fsearch-fda-guidance-documents%2Fpublic-availability-advisory-committee-members-financial-interest-information-and-waivers" class="lcds-share__btn lcds-share--default__btn-facebook js-share" id="fb-share" target="_blank"><span class="fa icon-facebook" aria-hidden="true"></span>Share</a> </li> <li class="lcds-share__item"> <a href="https://x.com/intent/tweet/?text=Public%20Availability%20of%20Advisory%20Committee%20Members%27%20Financial%20Interest%20Information%20and%20Waivers&url=https://www.fda.gov%2Fregulatory-information%2Fsearch-fda-guidance-documents%2Fpublic-availability-advisory-committee-members-financial-interest-information-and-waivers" target="_blank" class="lcds-share__btn lcds-share--default__btn-x-twitter js-share" id="twitter-share"> <svg class="icon-svg-inline" aria-hidden="true"> <use href="/themes/custom/preview/assets/images/fa-icons.svg#icon-x-twitter"> </svg> Post </a> </li> <li class="lcds-share__item hidden-xs"> <a href="https://www.linkedin.com/shareArticle?mini=true&url=https://www.fda.gov%2Fregulatory-information%2Fsearch-fda-guidance-documents%2Fpublic-availability-advisory-committee-members-financial-interest-information-and-waivers&title=Public%20Availability%20of%20Advisory%20Committee%20Members%27%20Financial%20Interest%20Information%20and%20Waivers&source=FDA" class="lcds-share__btn lcds-share--default__btn-linkedin js-share" id="linkedin-share" target="_blank"><span class="fa icon-linkedin" aria-hidden="true"></span>Linkedin</a> </li> <li class="lcds-share__item"> <a href="mailto:?subject=Public%20Availability%20of%20Advisory%20Committee%20Members%27%20Financial%20Interest%20Information%20and%20Waivers&body=https://www.fda.gov%2Fregulatory-information%2Fsearch-fda-guidance-documents%2Fpublic-availability-advisory-committee-members-financial-interest-information-and-waivers" class="lcds-share__btn lcds-share--default__btn-mail"><span class="fa icon-envelope" aria-hidden="true"></span>Email</a> </li> <li class=" lcds-share__item hidden-xs"> <a href="javascript:window.print();" title="Print this page" class="lcds-share__btn lcds-share--default__btn-print"><span class="fa icon-print" aria-hidden="true"></span>Print</a> </li> </ul> <div class="form-group"> </div> </div> </div> </section> </header> <div class="col-md-8 col-md-push-2" role="main"> <div class="inset-column"> <dl class="lcds-description-list--grid"> <dt class="cell-1_2">Issued by:</dt> <dd class="cell-2_2"><a href="/regulatory-information/search-fda-guidance-documents/public-availability-advisory-committee-members-financial-interest-information-and-waivers"></a> <div class="field field--name-field-issuing-office-taxonomy field--type-entity-reference field--label-above"> <div class="field--label">Guidance Issuing Office</div> <div class="field--items"> <div class="field--item">Office of the Commissioner, Office of Clinical Policy and Programs, Office of Clinical Policy</div> </div> </div> </dd> </dl> </div> <h2><strong>Table of Contents</strong></h2> <ol type="I"> <li><strong><a href="#intro">Introduction</a></strong></li> <li><strong><a href="#applicability">Applicability</a></strong></li> <li><a href="#background"><strong>Background and Purpose</strong></a></li> <li><a href="#legal"><strong>Legal Framework</strong></a></li> <li><a href="#disclosure"><strong>Disclosure of Certain Financial Interests and Waivers</strong></a></li> </ol> <p><strong><a href="#appendix1">Appendix 1:</a> </strong>Food and Drug Administration Advisory Committee Member Acknowledgement of Disclosure of Financial Interests</p> <p><strong><a href="#appendix2">Appendix 2:</a></strong> Waiver to Allow Participation in a Food and Drug Administration Advisory Committee Meeting</p> <h2><strong>Reference Information</strong></h2> <ul> <li><a href="#about">About this guidance document</a></li> <li><a href="#comment">How to comment on this document</a></li> <li><a href="#copies">To obtain copies of this document</a></li> <li><a href="#questions">For questions regarding this document</a></li> <li><a href="#contact">FDA contact information</a></li> <li><a href="#footnotes">Footnotes</a></li> </ul> <hr> <h2><strong><a id="intro" name="intro"></a>I. Introduction</strong></h2> <p>This guidance is intended to help the public, Food and Drug Administration (FDA) advisory committee members, and FDA staff to understand and implement statutory requirements and FDA policy regarding public availability of information about financial interests and waivers<a href="#_ftn2" id="_ftnref2" name="_ftnref2"><sup>2</sup></a> granted by FDA to permit individuals to participate in advisory committee meetings subject to the Federal Advisory Committee Act (FACA) (5 U.S.C. App.). This guidance describes the basis and provides a format for public disclosure of certain financial interests by special Government employees (SGEs) and regular Government employees participating in these advisory committee meetings, and provides a format for FDA waivers allowing participation in these meetings.<a href="#_ftn3" id="_ftnref3" name="_ftnref3"><sup>3</sup></a> This guidance also explains how and when these documents will be made publicly available by FDA.</p> <p>FDA's guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word <em>should</em> in Agency guidances means that something is suggested or recommended, but not required.</p> <h2><strong><a id="applicability" name="applicability"></a>II. Applicability</strong></h2> <p>This guidance applies to SGEs and regular Government employees invited to participate in FDA advisory committees subject to FACA. The types of advisory committee meetings within the scope of this guidance are meetings involving particular matters as defined in regulations issued by the Office of Government Ethics (OGE). <em>See</em> 5 CFR § 2640.103(a)(1).<a href="#_ftn4" id="_ftnref4" name="_ftnref4"><sup>4</sup></a></p> <h2><strong><a id="background" name="background"></a>III. Background</strong><strong> and Purpose</strong></h2> <p>Advisory committees provide independent, expert advice on scientific, technical, and policy matters related to the development and evaluation of products regulated by FDA, such as human and animal drugs, biological products, medical devices, foods, cosmetics, and tobacco products. The advisory committee system enhances FDA’s ability to protect and promote the public health and maintain the public trust by enabling the agency to obtain the benefit of independent, professional expertise. Although advisory committees provide recommendations to FDA, final decisions are made by FDA. <em>See</em> 5 U.S.C. App. 2 § 9(b); 21 CFR § 14.5.</p> <p>Most FDA advisory committee members are appointed as SGEs. Advisory committee members may also be regular Government employees; for example, FDA may request participation by employees of the United States Department of Agriculture, the Centers for Disease Control and Prevention, or other Federal agencies for matters where such employees’ expertise is needed.</p> <p>FDA implements a rigorous process for soliciting and vetting candidates for advisory committee meetings to minimize any potential for financial conflicts of interest. In preparation for advisory committee meetings involving particular matters, SGEs invited to participate in the meetings are required to report to FDA any financial interests related to the subject matter of the advisory committee meeting. <em>See</em> 5 CFR § 2634.904(a)(2). Regular Government employees also report financial interests on a yearly basis and/or just prior to the advisory committee meeting they are planning to attend. <em>See </em>5 CFR §§ 2634.202 and 2634.904(a)(1). FDA reviews these reports, called Confidential Financial Disclosure Reports<a href="#_ftn5" id="_ftnref5" name="_ftnref5"><sup>5</sup></a> in advance of each upcoming meeting, once the meeting topics have been identified, to determine whether any financial conflicts of interest may exist for these individuals.<a href="#_ftn6" id="_ftnref6" name="_ftnref6"><sup>6</sup></a></p> <p>FDA seeks to identify all potential financial conflicts related to the particular matter before a committee. FDA reviews not only the financial interests of a potential advisory committee participant and his immediate family, but also the financial interests, of which he has knowledge, of the participant's business partners, organizations for which he serves as officer, director, trustee, general partner, or employee, and any prospective employer of the member (if there are ongoing employment negotiations or an agreement regarding future employment). <em>See</em> 18 U.S.C. § 208(a).</p> <p>FDA is authorized by statute to grant waivers to allow individuals with potentially conflicting financial interests to participate in meetings where it concludes, after close scrutiny, that certain criteria are met. <em>See</em> 18 U.S.C. § 208(b)(1) and (b)(3). The Agency has also issued a guidance document describing our policy for considering eligibility for advisory committee participation.<a href="#_ftn7" id="_ftnref7" name="_ftnref7"><sup>7</sup></a></p> <p>This document contains revisions to reflect the statutory changes in FDA’s authority after the implementation of the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA), and replaces previous guidance of the same title.<a href="#_ftn8" id="_ftnref8" name="_ftnref8"><sup>8</sup></a></p> <h2><strong><a id="legal" name="legal"></a>IV. Legal Framework</strong></h2> <p>Members of FDA’s advisory committees are subject to government wide conflict of interest statutes and standards of ethical conduct regulations. A federal conflict of interest statute, 18 U.S.C. § 208, prohibits an SGE or regular Government employee with a financial interest that can be affected by the particular matter before the advisory committee from participating in the advisory committee meeting unless a waiver is granted or the financial interest is covered by one of the regulatory exemptions found at 5 CFR Part 2640. The statute is applicable government-wide, and specifies the circumstances under which FDA may grant waivers to permit participation in specific meetings. An additional statutory requirement applies to FDA advisory committees. FDA is directed to disclose on its website the type, nature, and magnitude of the financial interests of each advisory committee member who has received a waiver under 18 U.S.C. § 208 and the reasons for granting each waiver prior to the advisory committee meeting, including, as appropriate, the public health interest in having the expertise of the member with respect to the particular matter.<a href="#_ftn9" id="_ftnref9" name="_ftnref9"><sup>9</sup></a> A waiver for an SGE must be based on a determination that the need for the SGE’s service outweighs the potential for a conflict of interest. This information must be published within specified time frames before advisory committee meetings. <em>See</em> § 712(c) of the FD&C Act.</p> <p>In addition to these statutory requirements regarding the disclosure of information about financial interests and corresponding waivers, FDA also has the authority to establish policies regarding the operation of advisory committees and participation of advisory committee members. <em>See</em> 21 U.S.C. § 393; 41 CFR §§ 102-3.105 and 102-3.130.</p> <h2><strong><a id="disclosure" name="disclosure"></a>V. Disclosure of Certain Financial Interests and Waivers</strong></h2> <p>To increase the transparency, consistency, and clarity of the advisory committee process, consistent with the requirements of § 712(c) of the FD&C Act described above, FDA has concluded that it is desirable to implement agency-wide procedures regarding disclosure of financial interest information that apply to all SGE and regular Government employees invited to participate in FDA advisory committee meetings subject to FACA. In preparation for each advisory committee meeting, to ensure individuals understand what information about their financial interests will be made public, FDA intends to request that individuals within the scope of this guidance acknowledge that FDA intends to publicly disclose the type, nature, and magnitude of any waived financial interests. FDA further intends to make the individuals’ participation in advisory committee meetings contingent upon their acknowledgement of FDA’s intention to publicly disclose this information.</p> <p>To facilitate such disclosure, FDA plans to prepare a document listing the financial interests for which a waiver is sought. A template that FDA intends to use when preparing this document, based on information already submitted by the individual,<a href="#_ftn10" id="_ftnref10" name="_ftnref10"><sup>10 </sup></a>is found in <a href="#appendix1">Appendix 1</a>. Using the template format, FDA will list personal and immediate family interests separately from other imputed interests. Other imputed financial interests are those that are attributed to the individual through his employer (i.e., the employer has a relevant financial interest) or through his position as an officer, director, trustee, or general partner. Even though the individual may have no personal involvement in these interests, imputed financial interests that can be affected by the particular matter before the advisory committee are considered conflicts of interest under the applicable law.</p> <p>First, FDA will identify the type of interest. The template provides several examples, such as stocks/investments and employment. Second, FDA will identify the nature of the interest. The template instructs that the name of the company or institution be identified, along with indicating whether the firm is the sponsor, a competing firm, or other affected entity. Third, FDA will indicate the magnitude of an interest by a dollar range, such as $0 to 5000. The agency will request that the individual in need of a waiver review the document and acknowledge his/her understanding that FDA will publicly disclose the information.</p> <p>FDA does not intend to publicly disclose financial interest information if the information is exempt from disclosure under the Freedom of Information Act or otherwise protected from disclosure by statute or regulation, except if necessary to describe the type, nature, and magnitude of the financial conflict being waived. For example, FDA would not disclose the name of a company or institution in which the committee member has a financial interest if doing so would reveal that company’s confidential commercial information.</p> <p>In addition, FDA is providing a template of the waivers that the agency grants (Appendix 2). FDA intends to write the waivers in a manner to ensure that information protected from disclosure by statute or regulation does not appear in the waivers. The waivers would therefore not typically require redaction when publicly disclosed as described in the following paragraph. However, if confidential information appears in other documents submitted, completed, or generated in the course of FDA’s review of financial interests and waiver requests, this information will continue to be protected from public disclosure in accordance with applicable statutory and regulatory requirements. <em>See, e.g.</em>, 21 CFR Part 20.</p> <p>For waivers that are granted, the disclosure statement will be posted on FDA’s website, along with the agency’s waiver. FDA will post these documents on the FDA website<a href="#_ftn11" id="_ftnref11" name="_ftnref11"><sup>11</sup></a> at least 15 days prior to the relevant advisory committee meeting, except for financial conflicts of interest that do not become known to FDA until shortly before the meeting. For conflicts of interest that FDA becomes aware of less than 30 days prior to the meeting and for which a waiver is issued, FDA will post the documents as soon as practicable and no later than the day of the meeting. These time frames are consistent with the requirements of section 712(c) of the FD&C Act. The agency also plans to make the disclosure statements and waiver documents public at corresponding advisory committee meetings.</p> <p>Additionally, FDA plans to post a roster<a href="#_ftn12" id="_ftnref12" name="_ftnref12"><sup>12</sup></a> of all advisory committee members expected to attend a specific meeting at the same time briefing materials for that meeting are posted. <em>See</em> FDA’s Guidance for Industry: Advisory Committee Meetings – Preparation and Public Availability of Information Given to Advisory Committee Members.<a href="#_ftn13" id="_ftnref13" name="_ftnref13"><sup>13</sup></a></p> <hr> <h2><strong><a id="appendix1" name="appendix1"></a>Appendix 1</strong></h2> <p>Food and Drug Administration Advisory Committee Member Acknowledgment of Disclosure of Financial Interests</p> <p>Name of Advisory Committee Member:</p> <p>Committee:</p> <p>Meeting Date:</p> <p>I acknowledge that my participation in the advisory committee meeting described above is contingent upon public disclosure of the following financial interest(s) related to the agenda item: [Describe relevant agenda item],</p> <p>I. Personal/Immediate Family</p> <div class="table-responsive"> <table class="table table-bordered table-striped" summary="Three-column table with column headers"> <thead> <tr> <th class="text-center" scope="col"><strong>Type of Interest</strong></th> <th class="text-center" scope="col"> <p class="text-center"><strong>Nature</strong></p> </th> <th class="text-center" scope="col"> <p class="text-center"><strong>Magnitude</strong></p> </th> </tr> </thead> <tbody> <tr> <td valign="top"> <p>[Describe type of interest; e.g.:<br> Stocks/investments;<br> Employment;<br> Work as consultant/advisor;<br> Contracts/grants;<br> Patents/royalties/trademarks<br> Work as an expert witness<br> Teaching/speaking/writing]</p> </td> <td valign="top"> <p>[Describe nature of interest; i.e.:<br> name of company or institution and whether it is the sponsor, a competing firm, or other affected entity]</p> </td> <td valign="top"> <p>[Describe magnitude of interest; e.g.:<br> $0 – 5,000;<br> $5001 – 10,000;<br> $10,001 – 25,000;<br> $25,001 – 50,000]</p> </td> </tr> </tbody> </table> </div> <p>II. Other Imputed Interests<a href="#_ftn14" id="_ftnref14" name="_ftnref14"><sup>14</sup></a></p> <div class="table-responsive"> <table class="table table-bordered table-striped" summary="Three-column table with column headers"> <thead> <tr> <th class="text-center" scope="col"><strong>Type of Interest</strong></th> <th class="text-center" scope="col"> <p class="text-center"><strong>Nature</strong></p> </th> <th class="text-center" scope="col"> <p class="text-center"><strong>Magnitude</strong></p> </th> </tr> </thead> <tbody> <tr> <td valign="top"> <p>[Describe type of interest; e.g.:<br> Stocks/investments;<br> Employment;<br> Work as consultant/advisor;<br> Contracts/grants;<br> Patents/royalties/trademarks<br> Work as an expert witness<br> Teaching/speaking/writing]</p> </td> <td valign="top"> <p>[Describe nature of interest; i.e.:<br> name of company or institution and whether it is the sponsor, a competing firm, or other affected entity]</p> </td> <td valign="top"> <p>[Describe magnitude of interest; e.g.:<br> $0 – 50,000;<br> $50,001 – 100,000;<br> $100,001 – 300,000;<br> over $300,000]</p> </td> </tr> </tbody> </table> </div> <p>I hereby acknowledge that FDA will make this information publicly available if the agency grants a waiver<a href="#_ftn15" id="_ftnref15" name="_ftnref15"><sup>15</sup></a> allowing me to participate in the meeting described above. I understand that without public disclosure of these interests, I will not participate in the advisory committee meeting described above.</p> <p>Signature:</p> <p>Date:</p> <hr> <h2><strong><a id="appendix2" name="appendix2"></a>Appendix 2</strong></h2> <p><strong>Waiver to Allow Participation in a Food and Drug Administration Advisory Committee Meeting </strong></p> <p>Name of Advisory Committee Member:</p> <p>Committee:</p> <p>Meeting Date:</p> <p>Description of the Facts on Which the Waiver is Based:</p> <p>Type, Nature, and Magnitude of Financial Interest(s):</p> <p>Description of the Particular Matter to Which the Waiver Applies:</p> <p>Additional Facts (if any):</p> <p>Basis for Granting the Waiver:</p> <p>Certification: [Use one of the first two statements when describing a waiver granted under 18 U.S.C. § 208(b), depending on whether the individual is a regular Government employee or SGE.]</p> <p>________ The individual may participate, pursuant to 18 U.S.C. 208(b)(1) – The regular Government employee’s financial interest is not so substantial as to be deemed likely to affect the integrity of the services provided by that individual.</p> <p>________ The individual may participate, pursuant to 18 U.S.C. 208(b)(3) – The need for the individual’s services outweighs the potential for a conflict of interest created by the financial interest involved.</p> <p>Limitations on the Regular Government Employee or Special Government Employee’s Ability to Act:<br> ________ Non-voting<br> ________ Other (specify)</p> <p><br> Signature, Authorized FDA Official:</p> <p>Date:</p> <hr> <h2>Reference Information</h2> <p><a id="about" name="about"></a><strong>About this Guidance Document</strong></p> <p>This guidance represents the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the appropriate FDA staff. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.</p> <p><a id="comment" name="comment"></a><strong>How to Comment on This Guidance Document</strong></p> <p>Comments and suggestions may be submitted at any time for agency consideration to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability that is published in the <em>Federal Register</em>.</p> <p><a id="copies" name="copies"></a>To Obtain Copies of this Document</p> <p>Additional copies are available by mail from:</p> <p>Advisory Committee Oversight and Management Staff<br> Office of Special Medical Programs, OMPT<br> Food and Drug Administration<br> 10903 New Hampshire Avenue,<br> Building 32, rm. 5103<br> Silver Spring, Maryland 20993</p> <p>Or on the Web:</p> <p><a href="/regulatory-information/search-fda-guidance-documents/advisory-committee-guidance-documents">http://www.fda.gov/RegulatoryInformation/Guidances/ucm122045.htm</a></p> <p><a id="questions" name="questions"></a><strong>For Questions About This Document</strong></p> <p>For questions on the content of this guidance, contact Advisory Committee Oversight and Management Staff, at 301-796-8220.</p> <p><a id="contact" name="contact"></a><strong>FDA Contact Information</strong></p> <p>U.S. Department of Health and Human Services<br> Food and Drug Administration<br> Advisory Committee Oversight and Management Staff<br> Office of Special Medical Programs, OMPT</p> <hr> <h4><a id="footnotes" name="footnotes"></a>Footnotes</h4> <div> <div id="ftn1"> <p><a href="#_ftnref1" id="_ftn1" name="_ftn1">1</a> This guidance has been prepared by the Advisory Committee Oversight and Management Staff in the Office of the Commissioner at the Food and Drug Administration.</p> </div> <div id="ftn2"> <p><a href="#_ftnref2" id="_ftn2" name="_ftn2">2</a> For purposes of this guidance, the term "waiver" refers to determinations and certifications that the Agency is authorized to issue under 18 U.S.C. § 208(b)(1) and (b)(3), respectively.</p> </div> <div id="ftn3"> <p><a href="#_ftnref3" id="_ftn3" name="_ftn3">3</a> <em>See</em> "<a href="/regulatory-information/search-fda-guidance-documents/advisory-committee-guidance-documents" target>Guidance for the Public, FDA Advisory Committee Members, and FDA Staff on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees</a>." That document describes FDA’s policy for considering whether an individual invited to participate in an FDA advisory committee meeting has a potential conflict of interest under 18 U.S.C. 208 and whether, under the statute, a waiver to allow participation in an advisory committee meeting is appropriate.</p> </div> <div id="ftn4"> <p><a href="#_ftnref4" id="_ftn4" name="_ftn4">4</a> Particular matters involve deliberation, decision, or action that is focused upon the interests of specific persons or a discrete and identifiable class of persons, and include matters involving specific parties and matters of general applicability. <em>See also</em> 5 CFR § 2640.102(l)-(m).</p> </div> <div id="ftn5"> <p><a href="#_ftnref5" id="_ftn5" name="_ftn5">5</a> In rare cases, an individual who is a regular Government employee may file a Public Financial Disclosure Report.</p> </div> <div id="ftn6"> <p><a href="#_ftnref6" id="_ftn6" name="_ftn6">6</a> In addition, FDA screens advisory committee members broadly for covered relationships that could present even the appearance that they have conflicts of interest that could affect their impartiality. <em>See</em> 5 CFR § 2635.502. This guidance does not address this screening process.</p> </div> <div id="ftn7"> <p><a href="#_ftnref7" id="_ftn7" name="_ftn7">7</a> <em>See</em> FDA's "<a href="/[!--$ssDownloadLink('UCM125646')--]" target>Guidance for The Public, FDA Advisory Committee Members, and FDA Staff on Procedures for Determining Conflict of Interest and Eligibility for Participation in FDA Advisory Committees</a>." All guidance documents relevant to Advisory Committee matters may be accessed at: <a href="/regulatory-information/search-fda-guidance-documents/advisory-committee-guidance-documents" target>http://www.fda.gov/RegulatoryInformation/Guidances/ucm122045.htm</a></p> </div> <div id="ftn8"> <p><a href="#_ftnref8" id="_ftn8" name="_ftn8">8</a> Section 712 of the FD&C Act requires that FDA review its disclosure guidance at least every 5 years, and update guidances as appropriate. This revision is a result of that review.</p> </div> <div id="ftn9"> <p><a href="#_ftnref9" id="_ftn9" name="_ftn9">9</a>This statutory disclosure requirement has changed over time. For example, under § 505(n)(4) of the FD&C Act, enacted as part of the Food and Drug Administration Modernization and Accountability Act of 1997, advisory committee members serving on panels related to new drugs could only receive a waiver of a conflict of interest requirement “upon public disclosure of such conflict of interest if such waiver is necessary to afford the panel essential expertise.” The Food and Drug Administration Amendments Act of 2007 repealed § 505(n)(4) and enacted § 712. As enacted at that time, § 712 also contained provisions regarding waivers of conflicts of interests and public disclosures of such waivers. It had several differences from § 505(n)(4), including that it extended its conflict of interest rules to all FDA advisory committee members. In 2012, Congress enacted FDASIA, which amended § 712, including by removing the “essential expertise” agency-specific waiver standard. The requirement to make disclosures of waivers is now in § 712(c).</p> </div> <div id="ftn10"> <p><a href="#_ftnref10" id="_ftn10" name="_ftn10">10</a> <em>See</em> section III above.</p> </div> <div id="ftn11"> <p><a href="#_ftnref11" id="_ftn11" name="_ftn11">11</a> <a href="/committees-meeting-materials" target>http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/default.htm</a></p> </div> <div id="ftn12"> <p><a href="#_ftnref12" id="_ftn12" name="_ftn12">12</a> <a href="/committees-meeting-materials" target>http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/default.htm</a></p> </div> <div id="ftn13"> <p><a href="#_ftnref13" id="_ftn13" name="_ftn13">13</a> <a href="/regulatory-information/search-fda-guidance-documents/advisory-committee-guidance-documents" target>http://www.fda.gov/RegulatoryInformation/Guidances/ucm122045.htm</a></p> </div> <div id="ftn14"> <p><a href="#_ftnref14" id="_ftn14" name="_ftn14">14</a> Other imputed interests include those that are attributed to the individual through his employer (i.e., the employer has a relevant financial interest) or through his position as an officer, director, trustee, or general partner.</p> </div> <div id="ftn15"> <p><a href="#_ftnref15" id="_ftn15" name="_ftn15">15</a> Includes determinations under 18 U.S.C. § 208(b)(1) and certifications under 18 U.S.C. § 208(b)(3).</p> </div> </div> <div class="inset-column"> <hr> <h2>Submit Comments</h2> <div class="row"> <div class="col-xs-12 col-sm-12"> <p class="lcds-explainer-txt">Submit comments on this guidance document electronically via docket ID: <a href="https://www.regulations.gov/docket/FDA-2013-S-0610">FDA-2013-S-0610</a> - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions) </p> <p class="lcds-explainer-txt">If unable to submit comments online, please mail written comments to:</p> <p class="lcds-explainer-txt"> Dockets Management<br/> Food and Drug Administration<br/> 5630 Fishers Lane, Rm 1061<br/> Rockville, MD 20852 </p> <p class="lcds-explainer-txt">All comments should be identified with the title of the guidance.</p> </div> </div> </div>   </div> <aside class="col-md-2 col-md-push-2" role="complementary"> <section id="block-entityviewcontent-4" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="region region-"> <aside class="lcds-card lcds-card--border-top"> <ul role="menu" class="lcds-description-list"> <li role="menuitem" class="node-current-date lcds-description-list__item"> <div> <h2 class="lcds-description-list__item-heading">Content current as of:</h2> <p class="lcds-description-list__item-text"><time datetime="2018-03-27T06:15:00Z">03/27/2018</time> </p> </div> </li> <li role="menuitem" class="lcds-description-list__item"> <div> <h2 class="lcds-description-list__item-heading">Regulated Product(s)</h2> <ul role="menu" class="lcds-metadata-list"> <li role="menuitem">Animal & Veterinary</li> <li role="menuitem">Biologics</li> <li role="menuitem">Cosmetics</li> <li role="menuitem">Dietary Supplements</li> <li role="menuitem">Drugs</li> <li role="menuitem">Food & Beverages</li> <li role="menuitem">Medical Devices</li> <li role="menuitem">Radiation-Emitting Products</li> <li role="menuitem">Tobacco</li> <li role="menuitem">Food & Color Additives</li> </ul> <h2 class="lcds-description-list__item-heading">Topic(s)</h2> <ul role="menu" class="lcds-metadata-list"> <li role="menuitem">Advisory Committees</li> </ul> </div> </li> </ul> </aside> </div> </section> </aside> <aside class="col-md-2 col-md-pull-10" role="complementary"> <section id="block-entityviewcontent-3" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> <div class="region region-"> <p class="text-center"><a href="/regulatory-information/search-fda-guidance-documents" class="btn btn-default"><span class="fa fa-arrow-circle-left" aria-hidden="true"></span> Search for FDA <br>Guidance Documents</a></p> <nav id="section-nav"class="lcds-card lcds-section-nav lcds-section-nav--side hidden-xs hidden-sm"> <ul class="lcds-section-nav__list lcds-section-nav--side__list"> <li> <a href="/regulatory-information/search-fda-guidance-documents" title="Search for FDA Guidance Documents" class="lcds-section-nav__link lcds-section-nav--side__link lcds-section-nav__parent-link lcds-section-nav--side__parent-link"> Search for FDA Guidance Documents </a> <div class="views-element-container form-group"><div class="view view-in-this-section view-id-in_this_section view-display-id-block_4 js-view-dom-id-a228fba9d0c395a69902eb21a319a850dfbf56016f6e8f7c3c366833089f5dfb"> <div class="item-list"> <ul class="lcds-section-nav__active lcds-section-nav__list lcds-section-nav--side__list"> <li><a href="/regulatory-information/search-fda-guidance-documents/search-general-and-cross-cutting-topics-guidance-documents" class="lcds-section-nav__link lcds-section-nav--side__link">Search General and Cross-Cutting Topics Guidance Documents</a></li> <li><a href="/regulatory-information/search-fda-guidance-documents/advisory-committee-guidance-documents" class="lcds-section-nav__link lcds-section-nav--side__link">Advisory Committee Guidance Documents</a></li> <li><a href="/regulatory-information/search-fda-guidance-documents/import-and-export-guidance-documents" class="lcds-section-nav__link lcds-section-nav--side__link">Import and Export Guidance Documents</a></li> <li><a href="/regulatory-information/search-fda-guidance-documents/cross-cutting-guidance-documents" class="lcds-section-nav__link lcds-section-nav--side__link">Cross-cutting Guidance Documents</a></li> </ul> </div> </div> </div> <div class="views-element-container form-group"><div class="view view-in-this-section-sub view-id-in_this_section_sub view-display-id-block_1 js-view-dom-id-86d0658829d6dbf9a873d1e486c0c28ea17c21cdd97b18ff92af7cb30cfcbb55"> <div class="view-content"> <div> <ul class="lcds-section-nav__list"> <li><a href="/regulatory-information/search-fda-guidance-documents/guidances" class="lcds-section-nav__section-link lcds-section-nav__link lcds-section-nav--side__link">Guidances</a></li> </ul> </div> </div> </div> </div> </li> </ul> </nav> </div> </section> </aside> </article> </main> </div> </div> <div class="region region-subscribe"> <section id="block-entityviewcontent-5" data-block-plugin-id="entity_view:node" class="block block-ctools block-entity-viewnode clearfix"> </section> </div> <footer class="lcds-footer container-fluid"> <div class="row lcds-footer__primary"> <h2 id="footer-heading" class="sr-only">Footer Links</h2> <nav class="text-center"> <div class="col-sm-4"> <ul class="nav"> <li><a href="/about-fda/about-website/fdagov-archive" >FDA Archive</a></li> <li><a href="/about-fda" >About FDA</a></li> <li><a href="/about-fda/about-website/internet-accessibility" >Accessibility</a></li> </ul> </div> <div class="col-sm-4"> <ul class="nav"> <li><a href="/about-fda/visitor-information" >Visitor Information</a> </li> <li><a href="/about-fda/about-website/website-policies" >Website Policies / Privacy</a></li> <li><a href="/about-fda/jobs-and-training-fda/no-fear-act" >No FEAR Act</a></li> <li><a href="https://www.hhs.gov/vulnerability-disclosure-policy/index.html" >Vulnerability Disclosure Policy</a></li> </ul> </div> <div class="col-sm-4"> <ul class="nav"> <li><a href="/regulatory-information/freedom-information" title="Freedom of Information Act">FOIA</a></li> <li><a href="https://www.hhs.gov/" title="Health and Human Services" target="_blank">HHS.gov</a></li> <li><a href="https://www.usa.gov/" target="_blank">USA.gov</a></li> </ul> </div> </nav> </div> <div class="row lcds-footer__secondary"> <div class="col-sm-12 col-md-6 col-lg-4 lcds-footer__social-links"> <a href="/about-fda/contact-fda" class="btn btn-default btn-md">Contact FDA</a> <a href="https://www.facebook.com/FDA" title="Follow FDA on Facebook" class="no-disclaimer"> <span class="fa fa-facebook fa-2x" aria-hidden="true"> <span class="sr-only">Follow FDA on Facebook</span> </span> </a> <a href="https://x.com/US_FDA" title="Follow FDA on X" class="no-disclaimer"> <svg class="icon-svg-inline fa-2x" aria-hidden="true"> <use href="/themes/custom/preview/assets/images/fa-icons.svg#icon-x-twitter"> </svg> <span class="sr-only">Follow FDA on X</span> </a> <a href="https://instagram.com/FDA" title="Follow FDA on Instagram" class="no-disclaimer"> <span class="fa fa-instagram fa-2x" aria-hidden="true"> <span class="sr-only">Follow FDA on Instagram</span> </span> </a> <br class='visible-xs-inline'/> <a href="https://www.linkedin.com/company/fda/" title="Follow FDA on LinkedIn" class="no-disclaimer"> <span class="fa fa-linkedin fa-2x" aria-hidden="true"> <span class="sr-only">Follow FDA on LinkedIn</span> </span> </a> <a href="https://youtube.com/@US_FDA" title="View FDA videos on YouTube" class="no-disclaimer"> <span class="fa fa-youtube fa-2x" aria-hidden="true"> <span class="sr-only">View FDA videos on YouTube</span> </span> </a> <a href="/about-fda/contact-fda/subscribe-podcasts-and-news-feeds" title="Subscribe to FDA RSS feeds"> <span class="fa fa-rss fa-2x" aria-hidden="true"> <span class="sr-only">Subscribe to FDA RSS feeds</span> </span> </a> </div> <a href="/" title="FDA Homepage"> <div class="visible-lg-block col-lg-4 text-center lcds-footer__logo"> <span class="sr-only">FDA Homepage</span> </div> </a> <div class="col-sm-12 col-md-6 col-lg-4 text-center lcds-footer__contact-number"> <span class="fa fa-phone" aria-hidden="true"> </span> <span class="sr-only">Contact Number</span> 1-888-INFO-FDA (1-888-463-6332) </div> </div>  </footer> <a href="" id="btn-top" class="btn btn-primary btn-top"><span class="sr-only">Back to </span>Top</a> </div> <script type="application/json" data-drupal-selector="drupal-settings-json">{"path":{"baseUrl":"\/","pathPrefix":"","currentPath":"node\/365165","currentPathIsAdmin":false,"isFront":false,"currentLanguage":"en"},"pluralDelimiter":"\u0003","suppressDeprecationErrors":true,"fda_ckeditor_enhancements":{"basePath":"modules\/custom\/fda_ckeditor_enhancements"},"google_analytics":{"account":"G-273DTKB5QW","trackOutbound":true,"trackMailto":true,"trackTel":true,"trackDownload":true,"trackDownloadExtensions":"7z|aac|arc|arj|asf|asx|avi|bin|csv|doc(x|m)?|dot(x|m)?|exe|flv|gif|gz|gzip|hqx|jar|jpe?g|js|mp(2|3|4|e?g)|mov(ie)?|msi|msp|pdf|phps|png|ppt(x|m)?|pot(x|m)?|pps(x|m)?|ppam|sld(x|m)?|thmx|qtm?|ra(m|r)?|sea|sit|tar|tgz|torrent|txt|wav|wma|wmv|wpd|xls(x|m|b)?|xlt(x|m)|xlam|xml|z|zip"},"bootstrap":{"forms_has_error_value_toggle":1,"modal_animation":1,"modal_backdrop":"true","modal_focus_input":1,"modal_keyboard":1,"modal_select_text":1,"modal_show":1,"modal_size":"","popover_enabled":1,"popover_animation":1,"popover_auto_close":1,"popover_container":"body","popover_content":"","popover_delay":"0","popover_html":0,"popover_placement":"right","popover_selector":"","popover_title":"","popover_trigger":"click"},"ajax":[],"user":{"uid":0,"permissionsHash":"3aef67b4ac7d861d8624bf1f7ab2bc9cfc56d3c25b7d709dc15466dfa996dfb0"}}</script> <script src="/files/js/js_jmx6639WuKcEs1DgFSmm8g__5ByGF4YtLnPWvZO-XrM.js?scope=footer&delta=0&language=en&theme=preview&include=eJxljlEOwjAMQy_UUX6QuE2VtVmpaOuqCUPj9DAQA8FP5NiS_SZUpSsLCtvpo3cmAjGzo0p50eTF_hpGFlEudiRh0zrPia82ZoyUB9Elpxr_bN9TUzEjoKKdmm1omLmbKZDzZw5J0R3XE1XPhauKJe_RQ0J1irgCyAldPQKbtVrs8-4KwiXzqwel5bQ2vDJ32B-_TDM91iuUxW5qA_WdbgvHD3mg9tx6_9v6sIHdAfkmf6A"></script> <script type="text/javascript" src="/Dc2Go5/dCelR/Sewog/rk5-/5VYNNfD46DcX/DQdKdDY/XS/EsHSMaAwQB"></script></body> </html>

CINXE.COM

Public Availability of Advisory Committee Members' Financial Interest Information and Waivers | FDA