[Federal Register Volume 87, Number 155 (Friday, August 12, 2022)]
[Notices]
[Pages 49861-49863]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-17345]


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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(Revision 1); Draft Guidance for Industry; Availability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.

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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the availability of a draft guidance for industry (GFI) #95 (VICH 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 This draft guidance has 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DATES: Submit either electronic or written comments on the draft 
guidance by October 11, 2022 to ensure that the Agency considers your 
comment on this draft guidance before it begins work on the final 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:
     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 Bovines (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 #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 https://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm, 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. 2022-17345 Filed 8-11-22; 8:45 am]
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