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, 60433-60435 [2024-16408]
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<![CDATA[
Federal Register / Vol. 89, No. 143 / Thursday, July 25, 2024 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
approved under section 571 of the FD&C
Act (21 U.S.C. 360ccc). FDA may issue
an EUA only if, after consultation with
the HHS Assistant Secretary for
Preparedness and Response, the
Director of the National Institutes of
Health, and the Director of the Centers
for Disease Control and Prevention (to
the extent feasible and appropriate
given the applicable circumstances),
FDA 2 concludes: (1) that an agent
referred to in a declaration of emergency
or threat can cause a serious or lifethreatening disease or condition; (2)
that, based on the totality of scientific
evidence available to FDA, including
data from adequate and well-controlled
clinical trials, if available, it is
reasonable to believe that (A) the
product may be effective in diagnosing,
treating, or preventing (i) such disease
or condition; or (ii) a serious or lifethreatening disease or condition caused
by a product authorized under section
564, approved or cleared under the
FD&C Act, or licensed under section 351
of the PHS Act, for diagnosing, treating,
or preventing such a disease or
condition caused by such an agent; and
(B) the known and potential benefits of
the product, when used to diagnose,
prevent, or treat such disease or
condition, outweigh the known and
potential risks of the product, taking
into consideration the material threat
posed by the agent or agents identified
in a declaration under section
564(b)(1)(D) of the FD&C Act, if
applicable; (3) that there is no adequate,
approved, and available alternative to
the product for diagnosing, preventing,
or treating such disease or condition; (4)
in the case of a determination described
in section 564(b)(1)(B)(ii), that the
request for emergency use is made by
the Secretary of Defense; and (5) that
such other criteria as may be prescribed
by regulation are satisfied. No other
criteria for issuance have been
prescribed by regulation under section
564(c)(4) of the FD&C Act.
II. Electronic Access
An electronic version of this
document and the full text of the
Authorizations are available on the
internet and can be accessed from
https://www.fda.gov/emergencypreparedness-and-response/mcm-legalregulatory-and-policy-framework/
emergency-use-authorization.
III. The Authorizations
Having concluded that the criteria for
the issuance of the following
2 The Secretary of HHS has delegated the
authority to issue an EUA under section 564 of the
FD&C Act to the Commissioner of Food and Drugs.
VerDate Sep<11>2014
19:41 Jul 24, 2024
Jkt 262001
Authorizations under section 564(c) of
the FD&C Act are met, FDA has
authorized the emergency use of the
following products for diagnosing,
treating, or preventing COVID–19
subject to the terms of each
Authorization. The Authorizations in
their entirety, including any authorized
fact sheets and other written materials,
can be accessed from FDA’s web page
entitled ‘‘Emergency Use
Authorization,’’ available at https://
www.fda.gov/emergency-preparednessand-response/mcm-legal-regulatoryand-policy-framework/emergency-useauthorization. The lists that follow
include Authorizations issued from
April 20, 2024, through July 10, 2024,
and we have included explanations of
the reasons for their issuance, as
required by section 564(h)(1) of the
FD&C Act. In addition, the EUAs that
have been reissued can be accessed from
FDA’s web page: https://www.fda.gov/
emergency-preparedness-and-response/
mcm-legal-regulatory-and-policyframework/emergency-useauthorization.
FDA is hereby announcing the
following Authorizations for
multianalyte tests:
• iHealth Labs, Inc.’s iHealth COVID–
19/Flu A&B Rapid Test Pro, issued on
May 31, 2024.3
• Roche Molecular Systems, Inc.’s
cobas liat SARS–CoV–2, Influenza A/B
& RSV nucleic acid test, issued on June
07, 2024.4
3 As set forth in the EUA for this product, FDA
has concluded that: (1) SARS–CoV–2 can cause a
serious or life-threatening disease or condition,
including severe respiratory illness, to humans
infected by this virus; (2) based on the totality of
scientific evidence available to FDA, it is reasonable
to believe that the product may be effective in
diagnosing COVID–19 through the simultaneous
detection and differentiation of SARS–CoV–2,
influenza A virus and/or influenza B virus protein
antigens, and that the known and potential benefits
of the product when used for diagnosing COVID–
19, outweigh the known and potential risks of such
product; and (3) there is no adequate, approved,
and available alternative to the emergency use of
the product.
4 As set forth in the EUA for this product, FDA
has concluded that: (1) SARS–CoV–2 can cause a
serious or life-threatening disease or condition,
including severe respiratory illness, to humans
infected by this virus; (2) based on the totality of
scientific evidence available to FDA, it is reasonable
to believe that the product may be effective in
diagnosing COVID–19 through the simultaneous
qualitative detection and differentiation of SARS–
CoV–2, influenza A virus, influenza B virus, and/
or RSV RNA, and that the known and potential
benefits of the product when used for diagnosing
COVID–19, outweigh the known and potential risks
of such product; and (3) there is no adequate,
approved, and available alternative to the
emergency use of the product.
PO 00000
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60433
Dated: July 18, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–16358 Filed 7–24–24; 8:45 am]
BILLING CODE 4164–01–P
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.
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:
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
comment will be made public, you are
solely responsible for ensuring that your
comment does not include any
E:\FR\FM\25JYN1.SGM
25JYN1
60434
Federal Register / Vol. 89, No. 143 / Thursday, July 25, 2024 / Notices
ddrumheller on DSK120RN23PROD with NOTICES1
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
VerDate Sep<11>2014
19:41 Jul 24, 2024
Jkt 262001
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 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 selfaddressed 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, mai.huynh@fda.hhs.gov.
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
PO 00000
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Fmt 4703
Sfmt 4703
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
E:\FR\FM\25JYN1.SGM
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Federal Register / Vol. 89, No. 143 / Thursday, July 25, 2024 / Notices
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-fdaguidance-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
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
ddrumheller on DSK120RN23PROD with NOTICES1
[Docket No. FDA–2022–N–0150]
Revocation of Authorization of
Emergency Use of In Vitro Diagnostic
Device for Detection and/or Diagnosis
of COVID–19; Availability
AGENCY:
Food and Drug Administration,
HHS.
VerDate Sep<11>2014
19:41 Jul 24, 2024
Jkt 262001
ACTION:
Notice.
The Food and Drug
Administration (FDA) is announcing the
revocation of the Emergency Use
Authorization (EUA) (the Authorization)
issued to Mesa Biotech Inc., (a legal
entity of Thermo Fisher Scientific), for
the Accula SARS–CoV–2 Test. FDA
revoked the Authorization under the
Federal Food, Drug, and Cosmetic Act
(FD&C Act) as requested by the
Authorization holder. The revocation,
which includes an explanation of the
reasons for revocation, is reprinted at
the end of this document.
DATES: The revocation of the
Authorization for the Mesa Biotech
Inc.’s Accula SARS–CoV–2 Test is
effective as of May 22, 2024.
ADDRESSES: Submit written requests for
a single copy of the revocation to the
Office of Policy, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, Rm. 5431, Silver Spring,
MD 20993–0002. Send one selfaddressed adhesive label to assist that
office in processing your request or
include a fax number to which the
revocation may be sent. See the
SUPPLEMENTARY INFORMATION section for
electronic access to the revocation.
FOR FURTHER INFORMATION CONTACT: Kim
Sapsford-Medintz, Office of Product
Evaluation and Quality, Center for
Devices and Radiological Health, Food
and Drug Administration, 10903 New
Hampshire Ave., Bldg. 66, Rm. 3216,
Silver Spring, MD 20993–0002, 301–
796–0311 (this is not a toll-free
number).
SUPPLEMENTARY INFORMATION:
SUMMARY:
I. Background
Section 564 of the FD&C Act (21
U.S.C. 360bbb-3) as amended by the
Project BioShield Act of 2004 (Pub. L.
108–276) and the Pandemic and AllHazards Preparedness Reauthorization
Act of 2013 (Pub. L. 113–5) allows FDA
to strengthen the public health
protections against biological, chemical,
radiological, or nuclear agent or agents.
Among other things, section 564 of the
FD&C Act allows FDA to authorize the
use of an unapproved medical product
or an unapproved use of an approved
medical product in certain situations.
On March 23, 2020, FDA issued the
Authorization to Mesa Biotech Inc. (a
legal entity of Thermo Fisher Scientific),
for the Accula SARS–CoV–2 Test,
subject to the terms of the
Authorization. Notice of the issuance of
PO 00000
Frm 00087
Fmt 4703
Sfmt 4703
60435
this Authorization was published in the
Federal Register on June 5, 2020 (85 FR
34638), as required by section 564(h)(1)
of the FD&C Act.
Subsequent updates to the
Authorization were made available on
FDA’s website. The authorization of a
device for emergency use under section
564 of the FD&C Act may, pursuant to
section 564(g)(2) of the FD&C Act, be
revoked when the criteria under section
564(c) of the FD&C Act for issuance of
such authorization are no longer met
(section 564(g)(2)(B) of the FD&C Act),
or other circumstances make such
revocation appropriate to protect the
public health or safety (section
564(g)(2)(C) of the FD&C Act).
II. Authorization Revocation Request
In a request received by FDA on May
15, 2024, Mesa Biotech Inc. (a legal
entity of Thermo Fisher Scientific),
made by Thermo Fisher Scientific, Inc.
on behalf of Mesa Biotech Inc.,
requested the revocation of, and on May
22, 2024, FDA revoked, the
Authorization for the Mesa Biotech
Inc.’s Accula SARS–CoV–2 Test.
Because Mesa Biotech Inc., notified
FDA that they discontinued the
commercialization of the Accula SARS–
CoV–2 Test and requested FDA revoke
Mesa Biotech Inc.’s Accula SARS–CoV–
2 Test, FDA has determined that it is
appropriate to protect the public health
or safety to revoke this Authorization.
III. Electronic Access
An electronic version of this
document and the full text of the
revocations are available on the internet
at https://www.regulations.gov/.
IV. The Revocation
Having concluded that the criteria for
revocation of the Authorization under
section 564(g)(2)(C) of the FD&C Act are
met, FDA has revoked the EUA of Mesa
Biotech Inc.’s Accula SARS–CoV–2
Test. The revocation in its entirety
follows and provide an explanation of
the reasons for revocation, as required
by section 564(h)(1) of the FD&C Act.
E:\FR\FM\25JYN1.SGM
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]]>Agencies
[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]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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
