Type VII Veterinary Master File for Research and Development and Risk Reviews; Draft Guidance for Industry; Availability, 1143-1144 [2024-31531]
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Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices
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 21 CFR 1271 relating to
HCT/Ps, including establishing and
maintaining records, investigation and
reporting of adverse actions and
documentation of methods used in
facilities related to HCT/Ps, which,
includes but not limited to donor
screening, donor testing, and labeling
have been approved under OMB control
number 0910–0543.
Electronic Submissions
Food and Drug Administration
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’’).
[Docket No. FDA–2024–D–5376]
Written/Paper Submissions
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/vaccines-blood-biologics/
guidance-compliance-regulatoryinformation-biologics/biologicsguidances, https://www.fda.gov/
regulatory-information/search-fdaguidance-documents, or https://
www.regulations.gov.
Dated: December 27, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation,
and International Affairs.
[FR Doc. 2024–31538 Filed 1–6–25; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Type VII Veterinary Master File for
Research and Development and Risk
Reviews; Draft Guidance for Industry;
Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice of availability.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing the availability of a draft
guidance for industry (GFI) #260
entitled ‘‘Type VII Veterinary Master
File for Research and Development and
Risk Reviews.’’ This draft guidance,
when finalized, will describe FDA’s
current thinking regarding the use of
Type VII Veterinary Master Files (Type
VII VMFs). Type VII VMFs are
appropriate for research and
development of animal cells, tissues,
and cell- and tissue-based products
SUMMARY:
ddrumheller on DSK120RN23PROD with NOTICES1
(ACTPs), gene therapies, and heritable
intentional genomic alterations (IGAs)
in animals.
DATES: Submit either electronic or
written comments on the draft guidance
by March 10, 2025 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:
VerDate Sep<11>2014
18:44 Jan 06, 2025
Jkt 265001
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–
2024–D–5376 for ‘‘Type VII Veterinary
Master File for Research and
Development and Risk Reviews.’’
Received comments will be placed in
the docket and, except for those
submitted as ‘‘Confidential
Submissions,’’ publicly viewable at
PO 00000
Frm 00065
Fmt 4703
Sfmt 4703
1143
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)).
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:
Lynne Boxer, Center for Veterinary
Medicine, Food and Drug
E:\FR\FM\07JAN1.SGM
07JAN1
1144
Federal Register / Vol. 90, No. 4 / Tuesday, January 7, 2025 / Notices
II. Paperwork Reduction Act of 1995
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–0611,
lynne.boxer@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
ddrumheller on DSK120RN23PROD with NOTICES1
I. Background
FDA is announcing the availability of
a draft guidance for industry #260
entitled ‘‘Type VII Veterinary Master
File for Research and Development and
Risk Reviews.’’ A Type VII VMF is a file
that can receive submissions to FDA’s
Center for Veterinary Medicine (CVM)
that may contain confidential data and
information related to unique regulatory
considerations such as research and
development of an ACTP, an IGA in an
animal, gene therapy, or a risk review
for an ACTP or IGA in an animal, where
the information submitted is generally
not intended to support product
approval. The benefits of a Type VII
VMF include: (1) confidential exchange
of information with FDA that is not
subject to user fees, (2) an opportunity
for increased communication with FDA
during early stages of product
development, and (3) a process for
reporting research studies outside of an
investigational file.
The scope of this draft guidance is
limited to the use of Type VII VMFs for
research and development and risk
review requests. There are other uses of
Type VII VMFs, but they are not
addressed in this draft guidance.
The use of a Type VII VMF is
appropriate for research and
development of ACTPs, gene therapies,
and IGAs in animals, and for risk review
of ACTPs and IGAs in animals because,
for these types of novel products and
rapidly evolving technologies, there
may be unique regulatory
considerations, concerning different
types of issues, that may call for a
developer’s interactions with CVM at an
earlier stage than would normally take
place with traditional products that
CVM regulates. As described in the draft
guidance, developers should open a
Type VII VMF to cover these
interactions with CVM.
This level 1 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 Type VII Veterinary
Master File for Research and
Development and Risk Reviews. 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.
VerDate Sep<11>2014
18:44 Jan 06, 2025
Jkt 265001
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 21 CFR part 514 have
been approved under OMB control
number 0910–0032.
application to FDA’s Center for
Veterinary Medicine (CVM) or to get our
approval before marketing their animals
following CVM’s prior review of risk
factor data.
DATES: Submit either electronic or
written comments on the draft guidance
by March 10, 2025 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:
III. Electronic Access
Electronic Submissions
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/regulatoryinformation/search-fda-guidancedocuments, or https://
www.regulations.gov.
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’’).
Dated: December 27, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation,
and International Affairs.
[FR Doc. 2024–31531 Filed 1–6–25; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2024–D–4778]
Heritable Intentional Genomic
Alterations in Animals of FoodProducing Species for Use as Models
of Disease; Draft Guidance for
Industry; Availability
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Written/Paper Submissions
Notice of availability.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing the availability of a draft
guidance for industry (GFI) #251
entitled ‘‘Heritable Intentional Genomic
Alterations in Animals of FoodProducing Species for Use as Models of
Disease.’’ This draft guidance, when
finalized, will set forth FDA’s policy
regarding heritable intentional genomic
alterations (IGAs) in animals of foodproducing species, such as swine and
rabbits, that are intended to be marketed
for use as models of human or animal
disease in biomedical research under
contained and controlled conditions.
The draft guidance describes the
conditions under which we generally
may not expect developers of IGAs in
animal models of disease to submit an
SUMMARY:
PO 00000
Frm 00066
Fmt 4703
Sfmt 4703
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–
2024–D–4778 for ‘‘Heritable Intentional
Genomic Alterations in Animals of
Food-Producing Species for Use as
Models of Disease.’’ Received comments
will be placed in the docket and, except
E:\FR\FM\07JAN1.SGM
07JAN1
]]>Agencies
[Federal Register Volume 90, Number 4 (Tuesday, January 7, 2025)]
[Notices]
[Pages 1143-1144]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-31531]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2024-D-5376]
Type VII Veterinary Master File for Research and Development and
Risk Reviews; Draft Guidance for Industry; Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice of availability.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing the availability of a draft guidance for industry (GFI) #260
entitled ``Type VII Veterinary Master File for Research and Development
and Risk Reviews.'' This draft guidance, when finalized, will describe
FDA's current thinking regarding the use of Type VII Veterinary Master
Files (Type VII VMFs). Type VII VMFs are appropriate for research and
development of animal cells, tissues, and cell- and tissue-based
products (ACTPs), gene therapies, and heritable intentional genomic
alterations (IGAs) in animals.
DATES: Submit either electronic or written comments on the draft
guidance by March 10, 2025 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-2024-D-5376 for ``Type VII Veterinary Master File for Research and
Development and Risk Reviews.'' 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: Lynne Boxer, Center for Veterinary
Medicine, Food and Drug
[[Page 1144]]
Administration, 7500 Standish Pl., Rockville, MD 20855, 240-402-0611,
[email protected].
SUPPLEMENTARY INFORMATION:
I. Background
FDA is announcing the availability of a draft guidance for industry
#260 entitled ``Type VII Veterinary Master File for Research and
Development and Risk Reviews.'' A Type VII VMF is a file that can
receive submissions to FDA's Center for Veterinary Medicine (CVM) that
may contain confidential data and information related to unique
regulatory considerations such as research and development of an ACTP,
an IGA in an animal, gene therapy, or a risk review for an ACTP or IGA
in an animal, where the information submitted is generally not intended
to support product approval. The benefits of a Type VII VMF include:
(1) confidential exchange of information with FDA that is not subject
to user fees, (2) an opportunity for increased communication with FDA
during early stages of product development, and (3) a process for
reporting research studies outside of an investigational file.
The scope of this draft guidance is limited to the use of Type VII
VMFs for research and development and risk review requests. There are
other uses of Type VII VMFs, but they are not addressed in this draft
guidance.
The use of a Type VII VMF is appropriate for research and
development of ACTPs, gene therapies, and IGAs in animals, and for risk
review of ACTPs and IGAs in animals because, for these types of novel
products and rapidly evolving technologies, there may be unique
regulatory considerations, concerning different types of issues, that
may call for a developer's interactions with CVM at an earlier stage
than would normally take place with traditional products that CVM
regulates. As described in the draft guidance, developers should open a
Type VII VMF to cover these interactions with CVM.
This level 1 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 Type VII
Veterinary Master File for Research and Development and Risk Reviews.
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 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: December 27, 2024.
Kimberlee Trzeciak,
Deputy Commissioner for Policy, Legislation, and International Affairs.
[FR Doc. 2024-31531 Filed 1-6-25; 8:45 am]
BILLING CODE 4164-01-P
