International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products; “Effectiveness of Anthelmintics: Specific Recommendations for Felines (Revision 1)”; Draft Guidance for Industry; Availability, 49855-49857 [2022-17350]
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Federal Register / Vol. 87, No. 155 / Friday, August 12, 2022 / Notices
jspears on DSK121TN23PROD with NOTICES
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
https://www.regulations.gov. 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: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov 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 selfaddressed 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for electronic access to the draft
guidance document.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:
Aime´e Phillippi-Taylor, Center for
Veterinary Medicine (HFV–114), Food
and Drug Administration, 7500 Standish
Pl, Rockville, MD 20855, 240–402–0601,
Aimee.Phillippi-Taylor@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft GFI #109 (VICH GL15(R1))
entitled ‘‘Effectiveness of
Anthelmintics: Specific
Recommendations for Equines (Revision
1).’’ It should be read in conjunction
VerDate Sep<11>2014
17:38 Aug 11, 2022
Jkt 256001
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 equine 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 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
PO 00000
Frm 00057
Fmt 4703
Sfmt 4703
49855
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 Equines
(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 https://
www.fda.gov/animal-veterinary/
guidance-regulations/guidanceindustry, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: August 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–17347 Filed 8–11–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–D–1494] (Formerly
FDA–2000–D–0193)]
International Cooperation on
Harmonisation of Technical
Requirements for Registration of
Veterinary Medicinal Products;
‘‘Effectiveness of Anthelmintics:
Specific Recommendations for Felines
(Revision 1)’’; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
E:\FR\FM\12AUN1.SGM
Notice of availability.
12AUN1
49856
Federal Register / Vol. 87, No. 155 / Friday, August 12, 2022 / Notices
The Food and Drug
Administration (FDA or Agency) is
announcing the availability of a draft
guidance for industry (GFI) #113 (VICH
GL20(R1)) entitled ‘‘Effectiveness of
Anthelmintics: Specific
Recommendations for Felines (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.
ADDRESSES: You may submit comments
on any guidance at any time as follows:
SUMMARY:
jspears on DSK121TN23PROD with NOTICES
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov 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 https://www.regulations.gov.
• 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:
• 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.
• For written/paper comments
submitted to the Dockets Management
VerDate Sep<11>2014
17:38 Aug 11, 2022
Jkt 256001
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 Felines (Revision
1).’’ Received comments will be placed
in the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
https://www.regulations.gov or at the
Dockets Management Staff between 9
a.m. and 4 p.m., Monday through
Friday, 240–402–7500.
• 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
https://www.regulations.gov. 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: https://
www.govinfo.gov/content/pkg/FR-201509-18/pdf/2015-23389.pdf.
Docket: For access to the docket to
read background documents or the
electronic and written/paper comments
received, go to https://
www.regulations.gov 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)).
PO 00000
Frm 00058
Fmt 4703
Sfmt 4703
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 selfaddressed 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:
Aime´e Phillippi-Taylor, Center for
Veterinary Medicine (HFV–114), Food
and Drug Administration, 7500 Standish
Pl, Rockville, MD 20855, 240–402–0601,
aimee.phillippi-taylor@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of
a draft GFI #113 (VICH GL20(R1))
entitled ‘‘Effectiveness of
Anthelmintics: Specific
Recommendations for Felines (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 feline 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
E:\FR\FM\12AUN1.SGM
12AUN1
Federal Register / Vol. 87, No. 155 / Friday, August 12, 2022 / Notices
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:
Specific Recommendations for Felines
(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.
jspears on DSK121TN23PROD with NOTICES
III. Electronic Access
Persons with access to the internet
may obtain the draft guidance at https://
www.fda.gov/animal-veterinary/
guidance-regulations/guidanceindustry, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
VerDate Sep<11>2014
17:38 Aug 11, 2022
Jkt 256001
Dated: August 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022–17350 Filed 8–11–22; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2022–D–1494 (Formerly
FDA–2000–D–0193)]
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
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
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.
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:
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
Comments submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
PO 00000
Frm 00059
Fmt 4703
Sfmt 4703
49857
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 https://www.regulations.gov.
• 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:
• 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.
• 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 (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 https://www.regulations.gov
or at the Dockets Management Staff
between 9 a.m. and 4 p.m., Monday
through Friday, 240–402–7500.
• 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
E:\FR\FM\12AUN1.SGM
12AUN1
]]>Agencies
[Federal Register Volume 87, Number 155 (Friday, August 12, 2022)]
[Notices]
[Pages 49855-49857]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-17350]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2022-D-1494] (Formerly FDA-2000-D-0193)]
International Cooperation on Harmonisation of Technical
Requirements for Registration of Veterinary Medicinal Products;
``Effectiveness of Anthelmintics: Specific Recommendations for Felines
(Revision 1)''; Draft Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
[[Page 49856]]
SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry (GFI) #113 (VICH
GL20(R1)) entitled ``Effectiveness of Anthelmintics: Specific
Recommendations for Felines (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.
ADDRESSES: You may submit comments on any guidance at any time as
follows:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: https://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to https://www.regulations.gov
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 https://www.regulations.gov.
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:
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.
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 Felines (Revision 1).'' Received comments will be
placed in the docket and, except for those submitted as ``Confidential
Submissions,'' publicly viewable at https://www.regulations.gov or at
the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through
Friday, 240-402-7500.
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 https://www.regulations.gov.
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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to https://www.regulations.gov 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, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft GFI #113 (VICH
GL20(R1)) entitled ``Effectiveness of Anthelmintics: Specific
Recommendations for Felines (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 feline 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
[[Page 49857]]
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: Specific Recommendations for Felines
(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 https://www.fda.gov/animal-veterinary/guidance-regulations/guidance-industry, https://www.fda.gov/regulatory-information/search-fda-guidance-documents, or https://www.regulations.gov.
Dated: August 8, 2022.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2022-17350 Filed 8-11-22; 8:45 am]
BILLING CODE 4164-01-P
