Heritable Intentional Genomic Alterations in Animals: The Approval Process; Draft Guidance for Industry; Availability, 35834-35836 [2024-09279]
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Federal Register / Vol. 89, No. 86 / Thursday, May 2, 2024 / Notices
are categories of IGAs in animals that
pose less risk and, if so, what data or
information supports that contention.
No commenters provided data to
address the Agency’s questions other
than scientific literature references that
were not directly applicable or
conclusive.
In the notice announcing availability
of the draft guidance, FDA also asked
for comment on the appropriate
terminology for animals with
intentional genomic alterations.
Commenters expressed different
preferences, but there was no general
consensus on an appropriate term. FDA
has adopted ‘‘intentional genomic
alteration’’ or ‘‘IGA’’ in animals as the
term it will use to refer to intentional
genomic alterations in animals
regardless of whether they are
developed with genetic engineering,
including genome editing, or some other
modern molecular technology. This
term is simple and sufficiently broad to
encompass intentional genomic
alterations achieved through means that
currently exist and those yet to be
developed. Moreover, section
740(d)(4)(B) of the Federal Food, Drug,
and Cosmetic Act uses this term (21
U.S.C. 379j-12(d)(4)(B)). However, the
scope of the guidance does not include
induction of polyploidy by heat,
pressure, or chemical treatment, or
selective breeding or other assisted
reproductive technologies. Nonheritable intentional genomic alterations
in animals are also outside the scope of
this guidance document.
Changes FDA has made in response to
comments include:
• Reorganization and use of plain
language to make FDA’s regulatory
approach clearer to stakeholders;
• Expansion of IGAs for which FDA
may decide it does not expect
submission of an application for
approval following a review of data and
a determination that the IGA meets the
Category 2 description in the guidance.
The new types of IGAs include:
D IGAs that are equivalent to genomic
sequences that are found in animals of
the same species with a history of safe
use in animal agriculture food
production and
D IGAs that are equivalent to what
could be theoretically achieved through
conventional breeding under certain
conditions,
including that the IGAs are not expected
to result in changes to food composition
and their intended use does not include
any effect on disease or other health
outcome;
• Clarification that if you are:
D ;a farmer, grower, or other entity
that just has animals with IGAs that
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FDA has approved or determined are
Category 2 on your farm or other
premises, including the offspring of
those animals,
D and you are not the developer of the
IGA in the animal or marketing the
animals with any new claims,
then, as a general matter, you do not
have to register or list with FDA and
you can engage in your ordinary
activities (e.g., breeding, growing, etc.)
without contacting FDA; and
• Clarification that those who breed
an animal containing an IGA that FDA
has approved or has determined is
Category 2:
D with another animal containing an
IGA that FDA has approved or also
determined is Category 2 or
D with an animal that does not
contain an IGA
and make no new claims do not need to
contact FDA and nothing further is
required.
The guidance announced in this
notice finalizes the draft guidance dated
January 2017.
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 ‘‘Heritable
Intentional Genomic Alterations in
Animals: Risk-Based Approach.’’ 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 regarding environmental
analysis in 21 CFR part 25 have been
approved under OMB control number
0910–0322; the collections of
information regarding applications in 21
CFR part 514 have been approved under
OMB control number 0910–0284; and
the collections of information regarding
investigational exemptions in 21 CFR
part 511 have been approved under
OMB control number 0910–0117.
III. Electronic Access
Persons with access to the internet
may obtain the guidance at https://
www.fda.gov/animal-veterinary/
guidance-regulations/guidanceindustry, https://www.fda.gov/
regulatory-information/search-fda-
PO 00000
Frm 00062
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guidance-documents, or https://
www.regulations.gov.
Dated: April 25, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–09278 Filed 5–1–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2019–D–2648]
Heritable Intentional Genomic
Alterations in Animals: The Approval
Process; 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) #187B
entitled ‘‘Heritable Intentional Genomic
Alterations in Animals: The Approval
Process.’’ This draft guidance is
intended to clarify FDA’s requirements
and recommendations for developers of
intentional genomic alterations (IGA) in
animals. The draft guidance is being
issued as one of two companion
documents. ‘‘Heritable Intentional
Genomic Alterations in Animals: The
Approval Process’’ describes how the
FDA approval process applies to
heritable IGAs in animals. FDA is
issuing GFI #187B as a draft guidance to
solicit comments that will enable the
Agency to update, and make as efficient
as possible, the approval process for
IGAs in animals. In addition, FDA
requests comments on questions that it
intends to address in the final version
of this guidance document. The
companion final guidance, GFI #187A
entitled ‘‘Heritable Intentional Genomic
Alterations in Animals: Risk-Based
Approach,’’ describes FDA’s risk-based
regulatory approach to the oversight of
heritable IGAs in animals. This means
that, for people or companies
developing certain types of IGAs in
animals, FDA may not expect them to
submit an application or get approval
before marketing their product.
DATES: Submit either electronic or
written comments on the draft guidance
by July 31, 2024 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:
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Federal Register / Vol. 89, No. 86 / Thursday, May 2, 2024 / 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’’).
khammond on DSKJM1Z7X2PROD with NOTICES
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–
2019–D–2648 for ‘‘Heritable Intentional
Genomic Alterations in Animals: The
Approval Process.’’ 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
VerDate Sep<11>2014
17:14 May 01, 2024
Jkt 262001
‘‘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:
Adam Moyer, Center for Veterinary
Medicine, Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 301–796–2319,
Adam.Moyer@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 19,
2017 (82 FR 6561), FDA published the
notice of availability for a draft GFI #187
entitled ‘‘Regulation of Intentionally
Altered Genomic DNA in Animals’’
giving interested persons until April 19,
2017, to comment on the draft guidance.
PO 00000
Frm 00063
Fmt 4703
Sfmt 4703
35835
On April 13, 2017, we published a
notice announcing the extension of the
comment period to June 19, 2017 (82 FR
17844). FDA received numerous
comments on the draft guidance GFI
#187 and those comments were
considered as the guidance was revised.
As noted, this draft guidance, GFI
#187B, is intended to explain how
FDA’s approval process applies in the
context of products related to heritable
IGAs in animals.
The draft guidance is being issued as
one of two companion documents. Draft
GFI #187B, ‘‘Heritable Intentional
Genomic Alterations in Animals: The
Approval Process,’’ describes how the
FDA approval process applies to
heritable IGAs in animals. Final GFI
#187A, ‘‘Heritable Intentional Genomic
Alterations in Animals: Risk-Based
Approach,’’ whose notice of availability
is published elsewhere in this edition of
the Federal Register, describes FDA’s
risk-based approach to the oversight of
IGAs in animals.
FDA received and reviewed
comments on the draft guidance that
came from industry (companies that
produce IGAs and trade associations),
individual consumers, academics, nongovernmental organizations (consumer,
environmental), other Federal and State
government agencies, and individual
developers of IGAs in animals. Among
the changes made to the draft guidance,
we have:
• Indicated our willingness to
consider multiple heritable IGAs or a
single IGA in multiple lines or breeds of
animals of the same species under a
single application;
• Clarified that FDA’s review of
applications is subject to specific
timeframes;
• Acknowledged that it may not be
feasible to gather data on multiple
generations and encourage developers of
heritable IGAs in animals to contact
FDA to discuss alternative approaches
of demonstrating durability;
• Indicated that alternative
disposition methods for investigational
animals may be acceptable if the
sponsor contacts FDA’s Center for
Veterinary Medicine;
• Further described post-market
records and reports requirements and
clarified who they apply to; and
• Provided additional information on
establishment registration requirements,
including explaining that, as a general
matter, pet stores, farms, or other animal
production facilities do not have to
register or list with FDA and can engage
in ordinary activities (e.g., breeding,
growing, etc.) without contacting FDA.
FDA is issuing this draft guidance to
solicit public comment that will further
E:\FR\FM\02MYN1.SGM
02MYN1
35836
Federal Register / Vol. 89, No. 86 / Thursday, May 2, 2024 / Notices
khammond on DSKJM1Z7X2PROD with NOTICES
improve it. To help inform our thinking
as we begin the process of further
updating the guidance, we invite
comment on the following questions:
1. What are some alternative strategies
for providing data that would support
approval of heritable IGAs in animals?
a. How can a developer demonstrate
the durability of a heritable IGA over
time in situations where collection of
data on multiple generations of animals
is difficult or not possible?
b. What are possible strategies a
developer could utilize to address the
approval requirements for multiple
heritable IGAs (e.g., multiple iterations
of the same alteration resulting in the
same intended phenotype or multiple
alterations resulting in more than one
intended phenotype) under a single
approval?
2. What areas of current good
manufacturing practices and good
laboratory practices specific to the
production of heritable IGAs in animals
do you believe need clarification
through the publication of additional
guidance?
3. Are there process improvements
(e.g., combining steps of the approval
process) (see page 16, section IV.C.
Recommended Process for Completing
Pre-approval Assessments for IGAs in
Animals, of the guidance) that you
believe would make the approval
process easier to navigate?
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 ‘‘Heritable
Intentional Genomic Alterations in
Animals: The Approval Process.’’ 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 25 have been
approved under OMB control number
0910–0322; the collections of
information in 21 CFR part 58 have been
approved under OMB control number
0910–0119; the collections of
information in 21 CFR part 207 have
been approved under OMB control
VerDate Sep<11>2014
17:14 May 01, 2024
Jkt 262001
number 0910–0045; the collections of
information in 21 CFR part 211 have
been approved under OMB control
number 0910–0139; the collections of
information in 21 CFR part 511 have
been approved under OMB control
number 0910–0117; the collections of
information in 21 CFR part 514 have
been approved under OMB control
number 0910–0284; and the collections
of information in 21 CFR 558.6(a)(4)
have been approved under OMB control
number 0910–0363.
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: April 25, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024–09279 Filed 5–1–24; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2023–N–5018]
Angela Maria Giron: Final Debarment
Order
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA) is issuing an
order under the Federal Food, Drug, and
Cosmetic Act (FD&C Act) permanently
debarring Angela Maria Giron, M.D.
from providing services in any capacity
to a person that has an approved or
pending drug product application. FDA
bases this order on a finding that Dr.
Giron was convicted of a felony under
Federal law for conduct relating to the
development or approval, including the
process for development or approval, of
any drug product. Dr. Giron was given
notice of the proposed debarment and
an opportunity to request a hearing
within the timeframe prescribed by
regulation. As of February 16, 2024 (30
days after receipt of the notice), Dr.
Giron has not responded. Dr. Giron’s
failure to respond and request a hearing
constitutes a waiver of Dr. Giron’s right
to a hearing concerning this matter.
DATES: This order is applicable May 2,
2024.
SUMMARY:
PO 00000
Frm 00064
Fmt 4703
Sfmt 4703
Any application by Dr.
Giron for special termination of
debarment under section 306(d)(4) of
the FD&C Act (21 U.S.C. 335a(d)(4)) may
be submitted at any time as follows:
ADDRESSES:
Electronic Submissions
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
instructions for submitting comments.
An application submitted electronically,
including attachments, to https://
www.regulations.gov will be posted to
the docket unchanged. Because your
application will be made public, you are
solely responsible for ensuring that your
application 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
application, that information will be
posted on https://www.regulations.gov.
• If you want to submit an
application with confidential
information that you do not wish to be
made available to the public, submit the
application as a written/paper
submission and in the manner detailed
(see ‘‘Written/Paper Submissions’’ and
‘‘Instructions’’).
Written/Paper Submissions
• 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 a written/paper application
submitted to the Dockets Management
Staff, FDA will post your application, as
well as any attachments, except for
information submitted, marked, and
identified, as confidential, if submitted
as detailed in ‘‘Instructions.’’
Instructions: All applications must
include the Docket No. FDA–2023–N–
5018. Received applications 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 an application with confidential
information that you do not wish to be
made publicly available, submit your
application 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
E:\FR\FM\02MYN1.SGM
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]]>Agencies
[Federal Register Volume 89, Number 86 (Thursday, May 2, 2024)]
[Notices]
[Pages 35834-35836]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-09279]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2019-D-2648]
Heritable Intentional Genomic Alterations in Animals: The
Approval Process; 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)
#187B entitled ``Heritable Intentional Genomic Alterations in Animals:
The Approval Process.'' This draft guidance is intended to clarify
FDA's requirements and recommendations for developers of intentional
genomic alterations (IGA) in animals. The draft guidance is being
issued as one of two companion documents. ``Heritable Intentional
Genomic Alterations in Animals: The Approval Process'' describes how
the FDA approval process applies to heritable IGAs in animals. FDA is
issuing GFI #187B as a draft guidance to solicit comments that will
enable the Agency to update, and make as efficient as possible, the
approval process for IGAs in animals. In addition, FDA requests
comments on questions that it intends to address in the final version
of this guidance document. The companion final guidance, GFI #187A
entitled ``Heritable Intentional Genomic Alterations in Animals: Risk-
Based Approach,'' describes FDA's risk-based regulatory approach to the
oversight of heritable IGAs in animals. This means that, for people or
companies developing certain types of IGAs in animals, FDA may not
expect them to submit an application or get approval before marketing
their product.
DATES: Submit either electronic or written comments on the draft
guidance by July 31, 2024 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:
[[Page 35835]]
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-2019-D-2648 for ``Heritable Intentional Genomic Alterations in
Animals: The Approval Process.'' 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: Adam Moyer, Center for Veterinary
Medicine, Food and Drug Administration, 7500 Standish Pl., Rockville,
MD 20855, 301-796-2319, [email protected].
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of January 19, 2017 (82 FR 6561), FDA
published the notice of availability for a draft GFI #187 entitled
``Regulation of Intentionally Altered Genomic DNA in Animals'' giving
interested persons until April 19, 2017, to comment on the draft
guidance. On April 13, 2017, we published a notice announcing the
extension of the comment period to June 19, 2017 (82 FR 17844). FDA
received numerous comments on the draft guidance GFI #187 and those
comments were considered as the guidance was revised. As noted, this
draft guidance, GFI #187B, is intended to explain how FDA's approval
process applies in the context of products related to heritable IGAs in
animals.
The draft guidance is being issued as one of two companion
documents. Draft GFI #187B, ``Heritable Intentional Genomic Alterations
in Animals: The Approval Process,'' describes how the FDA approval
process applies to heritable IGAs in animals. Final GFI #187A,
``Heritable Intentional Genomic Alterations in Animals: Risk-Based
Approach,'' whose notice of availability is published elsewhere in this
edition of the Federal Register, describes FDA's risk-based approach to
the oversight of IGAs in animals.
FDA received and reviewed comments on the draft guidance that came
from industry (companies that produce IGAs and trade associations),
individual consumers, academics, non-governmental organizations
(consumer, environmental), other Federal and State government agencies,
and individual developers of IGAs in animals. Among the changes made to
the draft guidance, we have:
Indicated our willingness to consider multiple heritable
IGAs or a single IGA in multiple lines or breeds of animals of the same
species under a single application;
Clarified that FDA's review of applications is subject to
specific timeframes;
Acknowledged that it may not be feasible to gather data on
multiple generations and encourage developers of heritable IGAs in
animals to contact FDA to discuss alternative approaches of
demonstrating durability;
Indicated that alternative disposition methods for
investigational animals may be acceptable if the sponsor contacts FDA's
Center for Veterinary Medicine;
Further described post-market records and reports
requirements and clarified who they apply to; and
Provided additional information on establishment
registration requirements, including explaining that, as a general
matter, pet stores, farms, or other animal production facilities do not
have to register or list with FDA and can engage in ordinary activities
(e.g., breeding, growing, etc.) without contacting FDA.
FDA is issuing this draft guidance to solicit public comment that
will further
[[Page 35836]]
improve it. To help inform our thinking as we begin the process of
further updating the guidance, we invite comment on the following
questions:
1. What are some alternative strategies for providing data that
would support approval of heritable IGAs in animals?
a. How can a developer demonstrate the durability of a heritable
IGA over time in situations where collection of data on multiple
generations of animals is difficult or not possible?
b. What are possible strategies a developer could utilize to
address the approval requirements for multiple heritable IGAs (e.g.,
multiple iterations of the same alteration resulting in the same
intended phenotype or multiple alterations resulting in more than one
intended phenotype) under a single approval?
2. What areas of current good manufacturing practices and good
laboratory practices specific to the production of heritable IGAs in
animals do you believe need clarification through the publication of
additional guidance?
3. Are there process improvements (e.g., combining steps of the
approval process) (see page 16, section IV.C. Recommended Process for
Completing Pre-approval Assessments for IGAs in Animals, of the
guidance) that you believe would make the approval process easier to
navigate?
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
``Heritable Intentional Genomic Alterations in Animals: The Approval
Process.'' 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 25 have been approved under OMB control number 0910-
0322; the collections of information in 21 CFR part 58 have been
approved under OMB control number 0910-0119; the collections of
information in 21 CFR part 207 have been approved under OMB control
number 0910-0045; the collections of information in 21 CFR part 211
have been approved under OMB control number 0910-0139; the collections
of information in 21 CFR part 511 have been approved under OMB control
number 0910-0117; the collections of information in 21 CFR part 514
have been approved under OMB control number 0910-0284; and the
collections of information in 21 CFR 558.6(a)(4) have been approved
under OMB control number 0910-0363.
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: April 25, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-09279 Filed 5-1-24; 8:45 am]
BILLING CODE 4164-01-P
