[Federal Register Volume 89, Number 143 (Thursday, July 25, 2024)]
[Notices]
[Pages 60433-60435]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-16408]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-1999-D-2955 (formerly 1999D-4071)]


International Cooperation on Harmonisation of Technical 
Requirements for Registration of Veterinary Medicinal Products; 
Impurities: Residual Solvents in New Veterinary Medicinal Products, 
Active Substances and Excipients (Revision 2); 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 final guidance for industry (GFI) #100 (VICH GL 
18(R2)) entitled ``Impurities: Residual Solvents in New Veterinary 
Medicinal Products, Active Substances and Excipients (Revision 2).'' 
This 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 guidance is to recommend acceptable amounts for residual 
solvents in pharmaceuticals for the safety of the target animal as well 
as for the safety of residues in products derived from treated food-
producing animals. This revision updates the listings and 
classification of solvents.

DATES: The announcement of the guidance is published in the Federal 
Register on July 25, 2024.

ADDRESSES: You may submit either electronic or written comments on 
Agency guidances 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

[[Page 60434]]

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-1999-D-2955 (formerly 1999D-4071) for ``Impurities: Residual 
Solvents in New Veterinary Medicinal Products, Active Substances and 
Excipients (Revision 2).'' 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 this draft guidance to 
the Policy and Regulations Staff, 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 request or include a fax number to which the draft guidance may be 
sent. See the SUPPLEMENTARY INFORMATION section for information on 
electronic access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: Mai Huynh, Center for Veterinary 
Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville, 
MD 20855, 240-402-0669, [email protected].

SUPPLEMENTARY INFORMATION: 

I. Background

    FDA is announcing the availability of a final GFI #100 (VICH 
GL18(R2)) entitled ``Impurities: Residual Solvents in New Veterinary 
Medicinal Products, Active Substances and Excipients (Revision 2).'' 
Residual solvents in pharmaceuticals are defined in the guidance as 
organic volatile chemicals that are used or produced in the manufacture 
of active substances or excipients, or in the preparation of veterinary 
medicinal products. The solvents are not completely removed by 
practical manufacturing techniques. The objective of this guidance is 
to recommend acceptable amounts for residual solvents in 
pharmaceuticals for the safety of the target animal as well as for the 
safety of residues in products derived from treated food-producing 
animals. The guidance recommends use of less toxic solvents and 
describes levels considered to be toxicologically acceptable for some 
residual solvents. This revision updates the listings and 
classification of solvents.
    FDA has participated in efforts to enhance 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 Conference on 
Harmonization of Technical Requirements for Approval of 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.
    In the Federal Register of July 18, 2022 (87 FR 42728), FDA 
published the notice of availability for a draft guidance #100 (VICH 
GL18(R2)) entitled ``Impurities: Residual Solvents in New Veterinary 
Medicinal Products, Active Substances and Excipients (Revision 2)'' 
giving interested persons until September 16, 2022, to comment on the 
draft guidance. FDA and other VICH member regulatory agencies did not

[[Page 60435]]

receive comments on the draft guidance. The guidance announced in this 
notice finalizes the draft guidance dated July 2022.
    This level 1 guidance is being issued consistent with FDA's good 
guidance practices regulation (21 CFR 10.115). The guidance represents 
the current thinking of FDA on ``Impurities: Residual Solvents in New 
Veterinary Medicinal Products, Active Substances and Excipients 
(Revision 2).'' 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. The 
previously approved collections of information are subject to review by 
the Office of Management and Budget (OMB) under the Paperwork Reduction 
Act of 1995 (PRA) (44 U.S.C. 3501-3521). The collections of information 
in section 512(n)(1) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 360b(n)(1)) have been approved under OMB control number 0910-
0669; 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 an electronic 
version of 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: July 22, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-16408 Filed 7-24-24; 8:45 am]
BILLING CODE 4164-01-P