Notice2022-17343
International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; Effectiveness of Anthelmintics: General Recommendations (Revision 1); Draft Guidance for Industry; Availability
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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The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #90 (VICH GL7(R1)) entitled "Effectiveness of Anthelmintics: General Recommendations (Revision 1)." This draft guidance has been developed for veterinary use by the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal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). The objective of this draft guidance is to provide study design recommendations that will facilitate the universal acceptance of the generated effectiveness data to fulfill the national/ regional requirements for anthelmintic drugs in animal species. This revision updates data analysis and isolate characterization recommendations, outlines how to approach new indications, and makes additional clarifying changes.
Full Text
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<title>Federal Register, Volume 87 Issue 155 (Friday, August 12, 2022)</title>
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[Federal Register Volume 87, Number 155 (Friday, August 12, 2022)]
[Notices]
[Pages 49853-49854]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[FR Doc No: 2022-17343]
[[Page 49853]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-D-1494]
International Cooperation on Harmonisation of Technical
Requirements for Registration of Veterinary Medicinal Products;
Effectiveness of Anthelmintics: General Recommendations (Revision 1);
Draft Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry (GFI) #90 (VICH
GL7(R1)) entitled ``Effectiveness of Anthelmintics: General
Recommendations (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 This draft guidance has been developed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). The objective of this draft guidance is to provide
study design recommendations that will facilitate the universal
acceptance of the generated effectiveness data to fulfill the national/
regional requirements for anthelmintic drugs in animal species. This
revision updates data analysis and isolate characterization
recommendations, outlines how to approach new indications, 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.
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-1999-D-0188 for ``Effectiveness of Anthelmintics: General
Recommendations (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#dfbeb6b2babaf1afb7b6b3b3b6afafb6f2abbea6b3b0ad9fb9bbbef1b7b7acf1b8b0a9"><span class="__cf_email__" data-cfemail="1a7b73777f7f346a72737676736a6a73376e7b637675685a7c7e7b34727269347d756c">[email protected]</span></a>.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
GFI #90 (VICH GL7(R1)) entitled ``Effectiveness of Anthelmintics:
General Recommendations (Revision 1).'' The objective of this guidance
is to provide study design recommendations that will facilitate the
universal acceptance of the generated effectiveness data to fulfill the
national/regional requirements for anthelmintic drugs in animal
species. This revision updates data analysis and isolate
characterization recommendations, outlines how to approach new
indications, 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
[[Page 49854]]
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 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. 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.
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: General Recommendations (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. 2022-17343 Filed 8-11-22; 8:45 am]
BILLING CODE 4164-01-P
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