Notice2022-17345
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: Specific Recommendations for Bovines (Revision 1); Draft Guidance for Industry; Availability
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
August 12, 2022
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #95 (VICH GL12(R1)) entitled "Effectiveness of Anthelmintics: Specific Recommendations for Bovines (Revision 1)." This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal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.
Full Text
<html>
<head>
<title>Federal Register, Volume 87 Issue 155 (Friday, August 12, 2022)</title>
</head>
<body><pre>
[Federal Register Volume 87, Number 155 (Friday, August 12, 2022)]
[Notices]
[Pages 49861-49863]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-17345]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-D-1494 (Formerly FDA-1990-D-0188)]
International Cooperation on Harmonisation of Technical
Requirements for Registration of Veterinary Medicinal Products;
Effectiveness of Anthelmintics: Specific Recommendations for Bovines
(Revision 1); Draft Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry (GFI) #95 (VICH
GL12(R1)) entitled ``Effectiveness of Anthelmintics: Specific
Recommendations for Bovines (Revision 1).'' This draft guidance has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.
DATES: 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.
[[Page 49862]]
ADDRESSES: You may submit comments on any guidance at any time as
follows:
Electronic Submissions
Submit electronic comments in the following way:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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'').
Written/Paper Submissions
Submit written/paper submissions as follows:
<bullet> Mail/Hand Delivery/Courier (for written/paper
submissions): Dockets Management Staff (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
<bullet> 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.''
Instructions: All submissions received must include the Docket No.
FDA-2022-D-1494 for ``Effectiveness of Anthelmintics: Specific
Recommendations for Bovines (Revision 1).'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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 21 CFR 10.20 and other
applicable disclosure law. For more information about FDA's posting of
comments to public dockets, see 80 FR 56469, September 18, 2015, or
access the information at: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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.
You may submit comments on any guidance at any time (see 21 CFR
10.115(g)(5)).
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 SUPPLEMENTARY INFORMATION section for
electronic access to the draft guidance document.
FOR FURTHER INFORMATION CONTACT: Aim[eacute]e Phillippi-Taylor, Center
for Veterinary Medicine (HFV-114), Food and Drug Administration, 7500
Standish Pl., Rockville, MD 20855, 240-402-0601, <a href="/cdn-cgi/l/email-protection#91d0f8fcf4f4bfc1f9f8fdfdf8e1e1f8bcc5f0e8fdfee3d1f7f5f0bff9f9e2bff6fee7"><span class="__cf_email__" data-cfemail="06476f6b636328566e6f6a6a6f76766f2b52677f6a697446606267286e6e7528616970">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft GFI #95 (VICH
GL12(R1)) entitled ``Effectiveness of Anthelmintics: Specific
Recommendations for Bovines (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: (1) to be
more specific for certain specific bovine issues not discussed in GFI
#90 (VICH GL7); (2) to highlight differences with GFI #90 (VICH GL7) on
effectiveness data recommendations; and (3) to 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.
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. 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.
The VICH Steering Committee is composed of member representatives
from the European Commission and European Medicines Agency;
AnimalhealthEurope; FDA--Center for Veterinary Medicine; 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. 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
[[Page 49863]]
preparation of documentation, is provided by HealthforAnimals.
This draft guidance is being issued consistent with FDA's good
guidance practices regulation (21 CFR 10.115). The draft guidance, when
finalized, will represent the current thinking of FDA on
``Effectiveness of Anthelmintics: Specific Recommendations for Bovines
(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.
II. Paperwork Reduction Act of 1995
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) (44 U.S.C. 3501-3521) 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 21 CFR part 514 have been approved under OMB Control
Number 0910-0032.
III. Electronic Access
Persons with access to the internet may obtain the draft guidance
at <a href="https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm">https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm</a>, <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents">https://www.fda.gov/regulatory-information/search-fda-guidance-documents</a>, or <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Dated: August 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-17345 Filed 8-11-22; 8:45 am]
BILLING CODE 4164-01-P
</pre><script data-cfasync="false" src="/cdn-cgi/scripts/5c5dd728/cloudflare-static/email-decode.min.js"></script></body>
</html>Indexed from Federal Register on August 12, 2022.
This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.