Federal Register :: International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: Specific Recommendations for Chickens-Gallus gallus (Revision 1); Draft Guidance for Industry; Availability

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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/2022-17351"> <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/2022-17351"> <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-2022-D-1494 (Formerly FDA-2000-D-0193)]</li></ol> </div> </div></div> <div id="agency"> <h1 id="h-1">AGENCY:</h1> <p id="p-1" data-page="49857">Food and Drug Administration, HHS.</p> </div> <div id="action"> <h1 id="h-2">ACTION:</h1> <p id="p-2" data-page="49857">Notice of availability.</p> </div> <div id="summary"> <h1 id="h-3">SUMMARY:</h1> <p id="p-3" data-page="49857">The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry GFI #114 (VICH GL21(R1)) entitled “Effectiveness of Anthelmintics: Specific Recommendations for Chickens—Gallus gallus (Revision 1).” This guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH). This revision clarifies the definition of adequate infection in individual animals, updates considerations for field studies, and makes additional clarifying changes. This revision clarifies the definition of adequate infection in individual animals, updates considerations for field studies, and makes additional clarifying changes.</p> </div> <div id="dates"> <h1 id="h-4">DATES:</h1> <p id="p-4" data-page="49857">Submit either electronic or written comments on the draft guidance by October 11, 2022 to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance.</p> </div> <div id="addresses"> <h1 id="h-5">ADDRESSES:</h1> <p id="p-5" data-page="49857">You may submit comments on any guidance at any time as follows:</p> <h3 id="h-6">Electronic Submissions</h3> <p id="p-6" data-page="49857">Submit electronic comments in the following way:</p> <ul class="bullets" > <li id="p-7" data-page="49857"> <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="49857">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="49857">Submit written/paper submissions as follows:</p> <ul class="bullets" > <li id="p-10" data-page="49857"> <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="49857">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="49857"> <em>Instructions:</em> All submissions received must include the Docket No. FDA-2022-D-1494 (formerly FDA-2000-D-0193) for “Effectiveness of Anthelmintics: Specific Recommendations for Chickens—Gallus gallus (Revision 1).” Received comments 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="49857">Confidential Submissions—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<span class="printed-page-inline unprinted-element document-markup" data-page="49858"> (<svg class="svg-icon svg-icon-doc-generic"><use xlink:href="/assets/fr-icons.svg#doc-generic"></use></svg> print page 49858) </span><span class="printed-page-details unprinted-element document-markup" id="page-49858" data-page="49858"><svg class="svg-icon svg-icon-doc-generic"><use xlink:href="/assets/fr-icons.svg#doc-generic"></use></svg></span> <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="49858"> <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> <p id="p-15" data-page="49858">You may submit comments on any guidance at any time (see <a href="https://www.ecfr.gov/current/title-21/section-10.115#p-10.115(g)(5)" class="cfr external" target="_blank" rel="noopener noreferrer">21 CFR 10.115(g)(5)</a>).</p> <p id="p-16" data-page="49858"> Submit written requests for single copies of the guidance to the Policy and Regulations Staff (HFV-6), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855. Send one self-addressed adhesive label to assist that office in processing your requests. See the <strong class="minor-caps">SUPPLEMENTARY INFORMATION</strong> section for electronic access to the draft guidance document. </p> </div> <div id="for-further-information-contact"> <h1 id="h-8">FOR FURTHER INFORMATION CONTACT:</h1> <p id="p-17" data-page="49858"> Aimée Phillippi-Taylor, Center for Veterinary Medicine (HFV-114), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0601, <em><a href="mailto:aimee.phillippi-taylor@fda.hhs.gov" class="email">aimee.phillippi-taylor@fda.hhs.gov</a>.</em></p> </div> </div> <div class="supplemental-info"> <h1 id="h-9">SUPPLEMENTARY INFORMATION:</h1> <p id="p-18" data-page="49858"></p> <h2 id="h-10">I. Background</h2> <p id="p-19" data-page="49858">FDA is announcing the availability of a draft guidance for industry GFI #114 (VICH GL21(R1)) entitled “Effectiveness of Anthelmintics: Specific Recommendations for Chickens—Gallus gallus (Revision 1).” It should be read in conjunction with GFI #90 (VICH GL7), “Effectiveness of Anthelmintics: General Recommendations,” which should be referred to for discussion of broad aspects for providing pivotal data to demonstrate product anthelmintic effectiveness. The purpose of this guidance is to: (1) be more specific for certain specific chicken issues not discussed in GFI #90 (VICH GL7); (2) highlight differences with GFI #90 (VICH GL7) on effectiveness data recommendations; and (3) give explanations for disparities with GFI #90 (VICH GL7). This revision clarifies the definition of adequate infection in individual animals, updates considerations for field studies, and makes additional clarifying changes.</p> <p id="p-20" data-page="49858">FDA has participated in efforts to enhance international harmonization and is committed to seeking scientifically based harmonized technical procedures for pharmaceutical development. One of the goals of harmonization is to identify, and then reduce, differences in technical requirements for drug development among regulatory agencies in different countries.</p> <p id="p-21" data-page="49858">FDA has actively participated in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use to develop harmonized technical requirements for the approval of human pharmaceutical and biological products among the European Union, Japan, and the United States. The VICH is a parallel initiative for veterinary medicinal products. The VICH is concerned with developing harmonized technical requirements for the approval of veterinary medicinal products in the European Union, Japan, and the United States, and includes input from both regulatory and industry representatives.</p> <p id="p-22" data-page="49858">The VICH Steering Committee is composed of member representatives from the European Commission and European Medicines Agency; AnimalhealthEurope; FDA—Center for Veterinary Medicine and U.S. Department of Agriculture—Center for Veterinary Biologics; the U.S. Animal Health Institute; the Japanese Ministry of Agriculture, Forestry and Fisheries; and the Japanese Veterinary Products Association.</p> <p id="p-23" data-page="49858">There are 10 observers to the VICH Steering Committee: One representative from government and one representative from industry of Australia, New Zealand, Canada, South Africa, and the United Kingdom. The World Organisation for Animal Health is an associate member of the VICH. The VICH Secretariat, which coordinates the preparation of documentation, is provided by HealthforAnimals.</p> <p id="p-24" data-page="49858">This draft guidance is being issued consistent with FDA's good guidance practices regulation (<a href="https://www.ecfr.gov/current/title-21/section-10.115" class="cfr external" target="_blank" rel="noopener noreferrer">21CFR 10.115</a>). This draft guidance, when finalized, will represent the current thinking of FDA on “Effectiveness of Anthelmintics: Specific Recommendations for Chickens—Gallus gallus (Revision 1).” It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations.</p> <h2 id="h-11">II. Paperwork Reduction Act of 1995</h2> <p id="p-25" data-page="49858">While this guidance contains no collection of information, it does refer to previously approved FDA collections of information. Therefore, clearance by the Office of Management and Budget (OMB) under the Paperwork Reduction Act of 1995 (PRA) (<a href="https://www.govinfo.gov/link/uscode/44/3501" class="usc external" target="_blank" rel="noopener noreferrer">44 U.S.C. 3501-3521</a>) is not required for this guidance. The previously approved collections of information are subject to review by OMB under the PRA. The collections of information in <a href="https://www.ecfr.gov/current/title-21/part-514" class="cfr external" target="_blank" rel="noopener noreferrer">21 CFR part 514</a> have been approved under OMB Control No. 0910-0032.</p> <h2 id="h-12">III. Electronic Access</h2> <p id="p-26" data-page="49858"> Persons with access to the internet may obtain the draft guidance at <em><a href="https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm" class="external" target="_blank" rel="noopener noreferrer">https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents" class="external" target="_blank" rel="noopener noreferrer">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>,</em> or <em><a href="https://www.regulations.gov" class="external" target="_blank" rel="noopener noreferrer">https://www.regulations.gov</a>.</em></p> <div class="signature"> <p class="signature-date">Dated: August 8, 2022.</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/2022-17351">FR Doc. 2022-17351</a> Filed 8-11-22; 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: 2022-17351 (87 FR 49857)</span></div></div> </div> </div> </div> <div class="clearfix" style="height: 100px;"></div> </div> </div>  </div>  </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>

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Federal Register :: International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: Specific Recommendations for Chickens-Gallus gallus (Revision 1); Draft Guidance for Industry; Availability