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Document Details</span></div></div></li> <li class="published " id="utility-nav-document-dates" tabindex="0"><span class="svg-tooltip" data-toggle="tooltip" data-title="Document Dates" role="button" aria-label="Document Dates" data-delay="{"show":300,"hide":0}" data-placement="top" data-title="Document Dates"><svg class="svg-icon svg-icon-calendar-alt "><use xlink:href="/assets/fr-icons-9d2306298f2aef758af4494a9e124d5a5239ed24836350c29d204e002cfe8bba.svg#calendar-alt"></use></svg></span><span class="content-nav-label " role="button">Document Dates</span><div class="fr-box fr-box-published-alt fr-box-full dropdown-menu dropdown-menu-right" role="menu"><div class="fr-seal-block fr-seal-block-header "><div class="fr-seal-content"><span class="h6">Published Content - Document Dates</span></div></div><div class="content-block "> <dl class='metadata_list'> <dt>Comments Close</dt> <dd>11/12/2024</dd> <dt>Dates Text</dt> <dd>Either electronic or written comments on the draft Strategy Document must be submitted by November 12, 2024.</dd> </dl> </div><div class="fr-seal-block fr-seal-block-footer"><span class="h6">Published Content - Document Dates</span></div></div></li> <li class="enhanced " id="utility-nav-toc" tabindex="0"><span class="svg-tooltip" data-toggle="tooltip" data-title="Table of Contents" role="button" aria-label="Table of Contents" data-delay="{"show":300,"hide":0}" data-placement="top" data-title="Table of Contents"><svg class="svg-icon svg-icon-book "><use xlink:href="/assets/fr-icons-9d2306298f2aef758af4494a9e124d5a5239ed24836350c29d204e002cfe8bba.svg#book"></use></svg></span><span class="content-nav-label " role="button">Table of Contents</span><div class="fr-box fr-box-enhanced fr-box-full dropdown-menu dropdown-menu-right" role="menu"><div class="fr-seal-block fr-seal-block-header "><div class="fr-seal-content"><span class="h6">Enhanced Content - Table of Contents</span></div></div><div class="content-block "> <p> This table of contents is a navigational tool, processed from the headings within the legal text of Federal Register documents. This repetition of headings to form internal navigation links has no substantive legal effect. </p> <ul class="table-of-contents fr-list with-bullets"> <li class="level-1"><a href="#agency" data-close-utility-nav="true">AGENCY:</a></li> <li class="level-1"><a href="#action" data-close-utility-nav="true">ACTION:</a></li> <li class="level-1"><a href="#summary" data-close-utility-nav="true">SUMMARY:</a></li> <li class="level-1"><a href="#dates" data-close-utility-nav="true">DATES:</a></li> <li class="level-1"><a href="#addresses" data-close-utility-nav="true">ADDRESSES:</a></li> <li class="level-1"><a href="#for-further-information-contact" data-close-utility-nav="true">FOR FURTHER INFORMATION CONTACT:</a></li> <li class="level-1"><a href="#h-9" data-close-utility-nav="true">SUPPLEMENTARY INFORMATION:</a></li> <li class="level-2"><a href="#h-10" data-close-utility-nav="true">I. Background</a></li> <li class="level-2"><a href="#h-11" data-close-utility-nav="true">II. Requested Information and Comments</a></li> </ul> </div><div class="fr-seal-block fr-seal-block-footer"><span class="h6">Enhanced Content - Table of Contents</span></div></div></li> <li class="divider"></li> <li class="enhanced utility-nav-comments " id="utility-nav-comments" tabindex="0"><span class="svg-tooltip" data-toggle="tooltip" data-title="Public Comments" role="button" aria-label="Public Comments" data-delay="{"show":300,"hide":0}" data-placement="top" data-title="Public Comments" icon_badge="5"><svg class="svg-icon svg-icon-chat "><use xlink:href="/assets/fr-icons-9d2306298f2aef758af4494a9e124d5a5239ed24836350c29d204e002cfe8bba.svg#chat"></use></svg></span><span class="content-nav-label " role="button">Public Comments</span><div class="fr-box fr-box-enhanced fr-box-full dropdown-menu dropdown-menu-right" role="menu"><div class="fr-seal-block fr-seal-block-header "><div class="fr-seal-content"><span class="h6">Enhanced Content - Public Comments</span></div></div><div class="content-block "> <svg class="svg-icon svg-icon-chat "><use xlink:href="/assets/fr-icons-9d2306298f2aef758af4494a9e124d5a5239ed24836350c29d204e002cfe8bba.svg#chat"></use></svg> <p> Comments are no longer being accepted. See <a data-close-utility-nav="true" href="#dates">DATES</a> for details. </p> <svg class="svg-icon svg-icon-conversation-alt "><use xlink:href="/assets/fr-icons-9d2306298f2aef758af4494a9e124d5a5239ed24836350c29d204e002cfe8bba.svg#conversation-alt"></use></svg> <div class="comment-count-by-docket "> <p> 5 comments have been received at Regulations.gov. </p> <p> Agencies review all submissions and may choose to redact, or withhold, certain submissions (or portions thereof). Submitted comments may not be available to be read until the agency has approved them. </p> <div class="table-container"> <table> <thead> <th>Docket Title</th> <th>Document ID</th> <th class="text-center">Comments</th> <th></th> </thead> <tbody> <tr> <td> FDA’s Strategy Document on Innovative Manufacturing Technologies </td> <td> <a target="_blank" rel="noopener noreferrer" href="https://www.regulations.gov/document/FDA-2024-N-3945-0001">FDA-2024-N-3945-0001</a> </td> <td> <a target="_blank" rel="noopener noreferrer" href="https://www.regulations.gov/document/FDA-2024-N-3945-0001/comment">5</a> </td> <td> <span class="svg-tooltip" data-toggle="tooltip" data-title="Last synced with regulations.gov at 11/14/2024 at 12:01 am" data-placement="left"><svg class="svg-icon svg-icon-info-circle "><use xlink:href="/assets/fr-icons-9d2306298f2aef758af4494a9e124d5a5239ed24836350c29d204e002cfe8bba.svg#info-circle"></use></svg></span> </td> </tr> </tbody> </table> </div> </div> </div><div class="fr-seal-block fr-seal-block-footer"><span class="h6">Enhanced Content - Public Comments</span></div></div></li> <li class="enhanced utility-nav-regs-dot-gov" id="utility-nav-regs-dot-gov" tabindex="0"><span class="svg-tooltip" data-toggle="tooltip" data-title="Regulations.gov Data" role="button" aria-label="Regulations.gov Data" data-delay="{"show":300,"hide":0}" data-placement="top" data-title="Regulations.gov Data"><svg class="svg-icon svg-icon-network-alt "><use xlink:href="/assets/fr-icons-9d2306298f2aef758af4494a9e124d5a5239ed24836350c29d204e002cfe8bba.svg#network-alt"></use></svg></span><span class="content-nav-label " role="button">Regulations.gov Data</span><div class="fr-box fr-box-enhanced fr-box-full dropdown-menu dropdown-menu-right" role="menu"><div class="fr-seal-block fr-seal-block-header "><div class="fr-seal-content"><span class="h6">Enhanced Content - Regulations.gov Data</span></div></div><div class="content-block "> <img alt="Regulations.gov Logo" class="regulations-dot-gov-logo" height="26" width="140" src="/assets/regulations_dot_gov_logo_sidebar-8dc5c757298949c20377261a36634705ced0a7eac7c0f1623af8223c8a57c3b2.png" /> <p> FederalRegister.gov retrieves relevant information about this document from Regulations.gov to provide users with additional context. This information is not part of the official Federal Register document. </p> <hr> <h5>FDA’s Strategy Document on Innovative Manufacturing Technologies</h5> <dl> <dt>Docket ID</dt> <dd> <a target="_blank" rel="noopener noreferrer" href="https://www.regulations.gov/docket/FDA-2024-N-3945">FDA-2024-N-3945</a> </dd> <dt>Supporting Documents</dt> <dd class="bulleted"> <a target="_blank" title="FDA’s Strategy Document on Innovative Manufacturing Technologies" rel="noopener noreferrer" href="https://www.regulations.gov/document?D=FDA-2024-N-3945-0002">FDA’s Strategy Document on Innovative Manufacturing Technologies</a> </dd> </dl> </div><div class="fr-seal-block fr-seal-block-footer"><span class="h6">Enhanced Content - Regulations.gov Data</span></div></div></li> <li class="enhanced utility-nav-sharing" id="utility-nav-sharing" tabindex="0"><span class="svg-tooltip" data-toggle="tooltip" data-title="Sharing" role="button" aria-label="Sharing" data-delay="{"show":300,"hide":0}" data-placement="top" data-title="Sharing"><svg class="svg-icon svg-icon-sharing "><use xlink:href="/assets/fr-icons-9d2306298f2aef758af4494a9e124d5a5239ed24836350c29d204e002cfe8bba.svg#sharing"></use></svg></span><span class="content-nav-label " role="button">Sharing</span><div class="fr-box fr-box-enhanced fr-box-full dropdown-menu dropdown-menu-right" role="menu"><div class="fr-seal-block fr-seal-block-header "><div class="fr-seal-content"><span class="h6">Enhanced Content - Sharing</span></div></div><div class="content-block "> <dl> <dt>Shorter Document URL</dt> <dd> <a class="shorter_url" href="https://www.federalregister.gov/d/2024-20665">https://www.federalregister.gov/d/2024-20665</a> <span class="copy-to-clipboard svg-tooltip" data-toggle="tooltip" data-title="Copy to Clipboard" data-title-copied="Copied to Clipboard" data-copy-text="https://www.federalregister.gov/d/2024-20665"><svg class="svg-icon svg-icon-content-copy "><use xlink:href="/assets/fr-icons-9d2306298f2aef758af4494a9e124d5a5239ed24836350c29d204e002cfe8bba.svg#content-copy"></use></svg></span> </dd> <dt>Email</dt> <dd> <a id="email-a-friend" href="" data-document-number="2024-20665"> Email this document to a friend </a> </dd> </dl> </div><div class="fr-seal-block fr-seal-block-footer"><span class="h6">Enhanced Content - Sharing</span></div></div></li> <li class="divider"></li> <li class="enhanced " id="utility-nav-print" tabindex="0"><span class="svg-tooltip" data-toggle="tooltip" data-title="Print" role="button" aria-label="Print" data-delay="{"show":300,"hide":0}" data-placement="top" data-title="Print"><svg class="svg-icon svg-icon-print "><use xlink:href="/assets/fr-icons-9d2306298f2aef758af4494a9e124d5a5239ed24836350c29d204e002cfe8bba.svg#print"></use></svg></span><span class="content-nav-label " role="button">Print</span><div class="fr-box fr-box-enhanced fr-box-full dropdown-menu dropdown-menu-right" role="menu"><div class="fr-seal-block fr-seal-block-header "><div class="fr-seal-content"><span class="h6">Enhanced Content - Print</span></div></div><div class="content-block "> <ul> <li><a href="#print">Print this document</a></li> </ul> </div><div class="fr-seal-block fr-seal-block-footer"><span class="h6">Enhanced Content - Print</span></div></div></li> <li class="enhanced utility-nav-document-statistics" id="utility-nav-document-statistics" tabindex="0"><span class="svg-tooltip" data-toggle="tooltip" data-title="Document Statistics" role="button" aria-label="Document Statistics" data-delay="{"show":300,"hide":0}" data-placement="top" data-title="Document Statistics"><svg class="svg-icon svg-icon-chart "><use xlink:href="/assets/fr-icons-9d2306298f2aef758af4494a9e124d5a5239ed24836350c29d204e002cfe8bba.svg#chart"></use></svg></span><span class="content-nav-label " role="button">Document Statistics</span><div class="fr-box fr-box-enhanced fr-box-full dropdown-menu dropdown-menu-right" role="menu"><div class="fr-seal-block fr-seal-block-header "><div class="fr-seal-content"><span class="h6">Enhanced Content - Document Statistics</span></div></div><div class="content-block "> <p> Document page views are updated periodically throughout the day and are cumulative counts for this document. 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Use the PDF linked in the document sidebar for the official electronic format.</p></div></div></div></div><div class="content-block "> <div id="fulltext_content_area" class="doc-content-area" data-short-url="https://www.federalregister.gov/d/2024-20665"> <div class="citation-target-icon cj-fancy-tooltip" data-tooltip="Click to copy a short url for this paragraph" data-short-url="https://www.federalregister.gov/d/2024-20665"> <span class="icon-fr2 icon-fr2-bookmark "></span> </div> <div class="citation-target-background"></div> <div class="preamble"> <div class="document-headings"><div class="fr-box fr-box-published-alt no-footer"> <div class="fr-seal-block fr-seal-block-header with-hover"><div class="fr-seal-content"> <span class="h6">Document Headings</span><div class="fr-seal-meta"><div class="fr-seal-desc"> <p> Document headings vary by document type but may contain the following: </p> <ol class="bullets"> <li> the agency or agencies that issued and signed a document </li> <li> the number of the CFR title and the number of each part the document amends, proposes to amend, or is directly related to </li> <li> the agency docket number / agency internal file number </li> <li> the RIN which identifies each regulatory action listed in the Unified Agenda of Federal Regulatory and Deregulatory Actions </li> </ol> <p> See the <a href="https://www.archives.gov/files/federal-register/write/handbook/ddh.pdf#page=9"> Document Drafting Handbook </a> for more details. </p> </div></div> </div></div> <div class="content-block "> <h6 class="agency">Department of Health and Human Services</h6> <h6 class="sub-agency">Food and Drug Administration</h6> <ol><li>[Docket No. FDA-2024-N-3945]</li></ol> </div> </div></div> <div id="agency"> <h1 id="h-1">AGENCY:</h1> <p id="p-1" data-page="74279">Food and Drug Administration, HHS.</p> </div> <div id="action"> <h1 id="h-2">ACTION:</h1> <p id="p-2" data-page="74279">Notice; establishment of a public docket; request for comments.</p> </div> <div id="summary"> <h1 id="h-3">SUMMARY:</h1> <p id="p-3" data-page="74279">The Food and Drug Administration (FDA or Agency) is announcing the publication of a draft Strategy Document for public comment outlining specific actions FDA will take during fiscal years 2023-2027 to facilitate the use of innovative manufacturing technologies. As part of the Prescription Drug User Fee Act (PDUFA) Reauthorization Performance Goals and Procedures Fiscal Years 2023-2027 (PDUFA VII), FDA committed to advance the use and implementation of innovative manufacturing. In connection with this effort, on June 8, 2023, FDA participated in a public workshop on the use of innovative manufacturing technologies for products regulated by the Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER), including barriers to their adoption. FDA also committed to issuing this draft Strategy Document for public comment. The actions described in the draft Strategy Document are based on lessons learned from FDA's experiences with submissions involving advanced manufacturing technologies as well as feedback from the workshop and other public input.</p> </div> <div id="dates"> <h1 id="h-4">DATES:</h1> <p id="p-4" data-page="74279">Either electronic or written comments on the draft Strategy Document must be submitted by November 12, 2024.</p> </div> <div id="addresses"> <h1 id="h-5">ADDRESSES:</h1> <p id="p-5" data-page="74279"> You may submit comments as follows. Please note that late, untimely filed comments will not be considered. The <em><a href="https://www.regulations.gov" class="external" target="_blank" rel="noopener noreferrer">https://www.regulations.gov</a></em> electronic filing system will accept comments until 11:59 p.m. Eastern Time at the end of November 12, 2024.Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are received on or before that date. </p> <h3 id="h-6">Electronic Submissions</h3> <p id="p-6" data-page="74279">Submit electronic comments in the following way:</p> <ul class="bullets" > <li id="p-7" data-page="74279"> <em>Federal eRulemaking Portal: <a href="https://www.regulations.gov" class="external" target="_blank" rel="noopener noreferrer">https://www.regulations.gov</a>.</em> Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to <em><a href="https://www.regulations.gov" class="external" target="_blank" rel="noopener noreferrer">https://www.regulations.gov</a></em> will be posted to the docket unchanged. Because your comment will be made public, you are solely responsible for ensuring that your comment does not include any confidential information that you or a third party may not wish to be posted, such as medical information, your or anyone else's Social Security number, or confidential business information, such as a manufacturing process. Please note that if you include your name, contact information, or other information that identifies you in the body of your comments, that information will be posted on <em><a href="https://www.regulations.gov" class="external" target="_blank" rel="noopener noreferrer">https://www.regulations.gov</a>.</em> </li> <li id="p-8" data-page="74279">If you want to submit a comment with confidential information that you do not wish to be made available to the public, submit the comment as a written/paper submission and in the manner detailed (see “Written/Paper Submissions” and “Instructions”).</li> </ul> <h3 id="h-7">Written/Paper Submissions</h3> <p id="p-9" data-page="74279">Submit written/paper submissions as follows:</p> <ul class="bullets" > <li id="p-10" data-page="74279"> <em>Mail/Hand Delivery/Courier (for written/paper submissions):</em> Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. </li> <li id="p-11" data-page="74279">For written/paper comments submitted to the Dockets Management Staff, FDA will post your comment, as well as any attachments, except for information submitted, marked and identified, as confidential, if submitted as detailed in “Instructions.”</li> </ul> <p id="p-12" data-page="74279"> <em>Instructions:</em> All submissions received must include the Docket No. FDA-2024-N-3945 for “FDA's Strategy Document on Innovative Manufacturing Technologies.” Received comments, those filed in a timely manner (see <strong class="minor-caps">ADDRESSES</strong> ), will be placed in the docket and, except for those submitted as “Confidential Submissions,” publicly viewable at <em><a href="https://www.regulations.gov" class="external" target="_blank" rel="noopener noreferrer">https://www.regulations.gov</a></em> or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240-402-7500. </p> <ul class="bullets" > <li id="p-13" data-page="74279"> <em>Confidential Submissions:</em> To submit a comment with confidential information that you do not wish to be made publicly available, submit your comments only as a written/paper submission. You should submit two copies total. One copy will include the information you claim to be confidential with a heading or cover note that states “THIS DOCUMENT CONTAINS CONFIDENTIAL INFORMATION.” The Agency will review this copy, including the claimed confidential information, in its consideration of comments. The second copy, which will have the claimed confidential information redacted/blacked out, will be available for public viewing and posted on <em><a href="https://www.regulations.gov" class="external" target="_blank" rel="noopener noreferrer">https://www.regulations.gov</a>.</em> Submit both copies to the Dockets Management Staff. If you do not wish your name and contact information to be made publicly available, you can provide this information on the cover sheet and not in the body of your comments and you must identify this information as “confidential.” Any information marked as “confidential” will not be disclosed except in accordance with <a href="https://www.ecfr.gov/current/title-21/section-10.20" class="cfr external" target="_blank" rel="noopener noreferrer">21 CFR 10.20</a> and other applicable disclosure law. For more information about FDA's posting of comments to public dockets, see <a href="/citation/80-FR-56469" class="fr-reference" data-reference="80 FR 56469">80 FR 56469</a>, September 18, 2015, or access the information at: <em><a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf" class="external" target="_blank" rel="noopener noreferrer">https://www.govinfo.gov/​content/​pkg/​FR-2015-09-18/​pdf/​2015-23389.pdf</a>.</em> </li> </ul> <p id="p-14" data-page="74279"> <em>Docket:</em> For access to the docket to read background documents or the electronic and written/paper comments received, go to <em><a href="https://www.regulations.gov" class="external" target="_blank" rel="noopener noreferrer">https://www.regulations.gov</a></em> and insert the docket number, found in brackets in the heading of this document, into the “Search” box and follow the prompts and/or go to the Dockets Management Staff, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500. </p> </div> <div id="for-further-information-contact"> <h1 id="h-8">FOR FURTHER INFORMATION CONTACT:</h1> <p id="p-15" data-page="74279"> Elisa A. Nickum, Center for Drug Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 75, Rm. 4521, Silver Spring, MD 20993, 301-796-4226, <em><a href="mailto:Elisa.Nickum@fda.hhs.gov" class="email">Elisa.Nickum@fda.hhs.gov</a>;</em> or James Myers, Center for Biologics Evaluation and Research, Food and Drug Administration, 10903 New Hampshire Ave., Bldg. 71, Rm. 7301, Silver Spring, MD 20993-0002, 240-402-7911. </p> </div> </div> <div class="supplemental-info"> <h1 id="h-9">SUPPLEMENTARY INFORMATION:</h1> <h2 id="h-10">I. Background</h2> <p id="p-16" data-page="74279"> Innovative manufacturing technologies—including but not limited to continuous manufacturing, distributed manufacturing, modern aseptic manufacturing equipment, and <span class="printed-page-inline unprinted-element document-markup" data-page="74280"> (<svg class="svg-icon svg-icon-doc-generic"><use xlink:href="/assets/fr-icons.svg#doc-generic"></use></svg> print page 74280) </span><span class="printed-page-details unprinted-element document-markup" id="page-74280" data-page="74280"><svg class="svg-icon svg-icon-doc-generic"><use xlink:href="/assets/fr-icons.svg#doc-generic"></use></svg></span> novel analytical methods—can increase product development speed, bolster supply chains, and prevent drug shortages. On June 8, 2023, FDA cosponsored and participated in a public workshop hosted by the Duke-Margolis Center for Health Policy on “Advancing the Utilization and Supporting the Implementation of Innovative Manufacturing Approaches.” At this workshop, interested parties from industry shared feedback on their interactions with FDA's CDER Emerging Technology Program (ETP) and CBER Advanced Technologies Team (CATT) to guide submissions from persons or organizations using innovative manufacturing technologies. Regulators, academic researchers, and industry representatives discussed the current barriers to using these technologies and shared ideas on how initiatives such as the newly created Advanced Manufacturing Technologies Designation Program (AMTDP) could alleviate these barriers. The workshop fulfilled a PDUFA VII commitment related to advancing utilization and implementation of innovative manufacturing, as well as section 506L(e)(1) of the Federal Food, Drug, and Cosmetic Act (<a href="https://www.govinfo.gov/link/uscode/21/356L" class="usc external" target="_blank" rel="noopener noreferrer">21 U.S.C. 356L(e)(1)</a>), as amended by section 3213 of the Food and Drug Omnibus Reform Act of 2022 regarding the AMTDP. </p> <p id="p-17" data-page="74280">Based on lessons learned from the Agency's experience with submissions involving advanced manufacturing, the topics discussed during the June 8, 2023, workshop, and other public input, FDA developed the draft Strategy Document on Innovative Manufacturing Technologies, which outlines the specific activities FDA intends to undertake to facilitate the use of innovative manufacturing technologies. Specifically, under the draft strategic plan FDA intends to undertake the following activities: continue to enhance the ETP and CATT as a mechanism to support innovation; implement the AMTDP in a manner that reflects feedback on eligibility criteria; continue to identify opportunities for international harmonization in support of advanced manufacturing; support and utilize ongoing initiatives for advanced manufacturing to address potential barriers; and support training in advanced manufacturing for FDA assessment staff.</p> <h2 id="h-11">II. Requested Information and Comments</h2> <p id="p-18" data-page="74280"> The draft Strategy Document on Innovative Manufacturing Technologies is available on FDA's website for Completed PDUFA VII Deliverables ( <em><a href="https://www.fda.gov/industry/prescription-drug-user-fee-amendments/completed-pdufa-vii-deliverables" class="external" target="_blank" rel="noopener noreferrer">https://www.fda.gov/​industry/​prescription-drug-user-fee-amendments/​completed-pdufa-vii-deliverables</a></em>). Interested persons are invited to provide detailed comments on all aspects of the draft Strategy Document. FDA encourages interested parties to provide the specific rationale and basis for their comments, including any available supporting data and information. </p> <div class="signature"> <p class="signature-date">Dated: September 6, 2024.</p> <p class="signature-name">Lauren K. Roth,</p> <p class="signature-title">Associate Commissioner for Policy.</p> </div> </div> <div class="end-matter"> <p class="frdoc">[<a href="/d/2024-20665">FR Doc. 2024-20665</a> Filed 9-11-24; 8:45 am]</p> <p class="billing-code">BILLING CODE 4164-01-P</p> </div> </div> </div><div class="fr-seal-block fr-seal-block-footer"><span class="h6">Published Document: 2024-20665 (89 FR 74279)</span></div></div> </div> </div> </div> <div class="clearfix" style="height: 100px;"></div> </div> </div> <!-- BOOTSTRAP SCOPE END --> </div> <!-- BOOTSTRAP SCOPE END --> </div> </main> <div class="site-footer" id="footer"> <div class="col-xs-3 col-md-3"> <h2>Home</h2> <ul class="bullets"> <li><a href="/" title="Home">Home</a></li> </ul> </div> <div class="col-xs-3 col-md-3"> <h2>Sections</h2> <ul class="bullets"> <li><a href="/money">Money</a></li> <li><a href="/environment">Environment</a></li> <li><a href="/world">World</a></li> <li><a href="/science-and-technology">Science & Technology</a></li> <li><a href="/business-and-industry">Business & Industry</a></li> <li><a href="/health-and-public-welfare">Health & Public Welfare</a></li> </ul> </div> <div class="col-xs-3 col-md-3"> <h2>Browse</h2> <ul class="bullets"> <li><a href="/agencies">Agencies</a></li> <li><a href="/topics">Topics (CFR Indexing Terms)</a></li> <li><a href="/documents/current">Dates</a></li> <li><a href="/public-inspection/current">Public Inspection</a></li> <li><a href="/presidential-documents/executive-orders">Executive Orders</a></li> </ul> </div> <div class="col-xs-3 col-md-3"> <h2>Search</h2> <ul class="bullets"> <li><a href="/documents/search">Document Search</a></li> <li><a href="/documents/search#advanced">Advanced Document Search</a></li> <li><a href="/public-inspection/search">Public Inspection Search</a></li> </ul> </div> <div class="col-xs-3 col-md-3"> <h2>Reader Aids</h2> <ul class="bullets"> <li><a href="/reader-aids/office-of-the-federal-register-announcements">Office of the Federal Register Announcements</a></li> <li><a href="/reader-aids/using-federalregister-gov">Using FederalRegister.Gov</a></li> <li><a href="/reader-aids/understanding-the-federal-register">Understanding the Federal Register</a></li> <li><a href="/reader-aids/recent-updates">Recent Site Updates</a></li> <li><a href="/reader-aids/federal-register-statistics">Federal Register & CFR Statistics</a></li> <li><a href="/reader-aids/videos-tutorials">Videos & Tutorials</a></li> <li><a href="/reader-aids/developer-resources">Developer Resources</a></li> <li><a href="/reader-aids/government-policy-and-ofr-procedures">Government Policy and OFR Procedures</a></li> <li><a href="/reader-aids/congressional-review">Congressional Review</a></li> </ul> </div> <div class="col-xs-3 col-md-3"> <h2>My FR</h2> <ul class="bullets"> <li><a href="/my/">My Clipboard</a></li> <li><a href="/my/subscriptions">My Subscriptions</a></li> <li><a href="/my/comments">My Comments</a></li> <li><a href="/auth/sign_in">Sign In</a></li> </ul> </div> <div class="col-xs-3 col-md-3"> <h2>Information</h2> <ul class="bullets"> <li><a href="/reader-aids/government-policy-and-ofr-procedures/about-this-site">About This Site</a></li> <li><a href="/reader-aids/government-policy-and-ofr-procedures/about-this-site#legal-status">Legal Status</a></li> <li><a href="/reader-aids/government-policy-and-ofr-procedures/contact-us">Contact Us</a></li> <li><a href="/reader-aids/government-policy-and-ofr-procedures/privacy">Privacy</a></li> <li><a href="/reader-aids/government-policy-and-ofr-procedures/accessibility">Accessibility</a></li> <li><a href="/reader-aids/government-policy-and-ofr-procedures/foia">FOIA</a></li> <li><a href="https://www.archives.gov/eeo/policy/no-fear-notice.html">No Fear Act</a></li> <li><a href="https://www.archives.gov/federal-register/write/newsletter/2024-may">Continuity Information</a></li> </ul> </div> <div id="zendesk-link"> <a href="" class="btn site-feedback-button" aria-label="Site Feedback"> <span class="icon-fr2 icon-fr2-Chat "></span> <span class="desktop-only">Site Feedback</span> </a> </div> </div> </body> </html>