82 FR 6561 - Regulation of Intentionally Altered Genomic DNA in Animals; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Federal Register Volume 82, Issue 12 (January 19, 2017)

Page Range		6561-6564
FR Document		2017-00839

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry (GFI) #187 entitled ``Regulation of Intentionally Altered Genomic DNA in Animals.'' This draft guidance revises GFI #187 entitled ``Regulation of Genetically Engineered Animals Containing Heritable Recombinant DNA Constructs'' (current GFI #187). Current GFI #187 clarifies FDA's requirements and recommendations for producers and developers of genetically engineered (GE) animals and their products. It describes how the new animal drug provisions of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) apply with respect to GE animals. This draft revision of current GFI #187 expands the scope of the guidance to include animals intentionally altered through use of genome editing techniques. The draft revised GFI #187 now applies to ``those animals whose genomes have been intentionally altered using modern molecular technologies.'' The Agency is seeking comment on the draft revised GFI #187, including the nomenclature that best describes these animals and on any existing empirical evidence indicating that certain types of genome editing may pose minimal risk.

Federal Register, Volume 82 Issue 12 (Thursday, January 19, 2017)

[Federal Register Volume 82, Number 12 (Thursday, January 19, 2017)]
[Notices]
[Pages 6561-6564]
From the Federal Register Online [www.thefederalregister.org]
[FR Doc No: 2017-00839]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-D-0394]

Regulation of Intentionally Altered Genomic DNA in Animals; Draft
Guidance for Industry; Availability

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of availability.

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SUMMARY: The Food and Drug Administration (FDA or Agency) is announcing
the availability of a draft guidance for industry (GFI) #187 entitled
``Regulation of Intentionally Altered Genomic DNA in Animals.'' This
draft guidance revises GFI #187 entitled ``Regulation of Genetically
Engineered Animals Containing Heritable Recombinant DNA Constructs''
(current GFI #187). Current GFI #187 clarifies FDA's requirements

[[Page 6562]]

and recommendations for producers and developers of genetically
engineered (GE) animals and their products. It describes how the new
animal drug provisions of the Federal Food, Drug, and Cosmetic Act (the
FD&C Act) apply with respect to GE animals. This draft revision of
current GFI #187 expands the scope of the guidance to include animals
intentionally altered through use of genome editing techniques. The
draft revised GFI #187 now applies to ``those animals whose genomes
have been intentionally altered using modern molecular technologies.''
The Agency is seeking comment on the draft revised GFI #187, including
the nomenclature that best describes these animals and on any existing
empirical evidence indicating that certain types of genome editing may
pose minimal risk.

DATES: Although you can comment on any guidance at any time (see 21 CFR
10.115(g)(5)), to ensure that the Agency considers your comment on this
draft guidance before it begins work on the final version of the
guidance, submit either electronic or written comments on the draft
guidance by April 19, 2017.

ADDRESSES: You may submit comments as follows:

Electronic Submissions

Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to http://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 http://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): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
For written/paper comments submitted to the Division of
Dockets Management, 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-2008-D-0394 for ``Regulation of Intentionally Altered Genomic DNA
in Animals.'' Received comments will be placed in the docket and,
except for those submitted as ``Confidential Submissions,'' publicly
viewable at http://www.regulations.gov or at the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
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 http://www.regulations.gov.
Submit both copies to the Division of Dockets Management. 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: http://www.fda.gov/regulatoryinformation/dockets/default.htm.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to http://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 Division of Dockets Management, 5630 Fishers
Lane, Rm. 1061, Rockville, MD 20852.
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, 7519 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: Laura R. Epstein, Center for
Veterinary Medicine (HFV-1), Food and Drug Administration, 7519
Standish Pl., Rockville, MD 20855, 301-796-8558,
[email protected].

SUPPLEMENTARY INFORMATION:

I. Background

FDA is announcing the availability, for public comment, of draft
revised GFI #187 entitled ``Regulation of Intentionally Altered Genomic
DNA in Animals.'' This draft guidance revises current GFI #187 entitled
``Regulation of Genetically Engineered Animals Containing Heritable
recombinant DNA Constructs'' to expand the scope of the guidance to
address animals intentionally altered through use of genome editing
techniques. FDA is also requesting comment on nomenclature and on
whether certain types of genome editing may pose minimal risk. Before
finalizing the draft revised guidance, the agency intends to modify its
regulatory approach if it receives evidence demonstrating low risk.
In the National Strategy for Modernizing the Regulatory System for
Biotechnology Products (the Strategy; released by the White House
Office of Science and Technology Policy on September 16, 2016),\1\ FDA
noted its intent to clarify its policy on the regulation of products
derived from genome editing techniques, including, as appropriate,
identifying and/or updating relevant existing guidance documents. FDA
also stated, as an example, its intent to update GFI #187, ``Regulation
of Genetically Engineered Animals Containing Heritable Recombinant DNA
Constructs,'' to clarify how developers of animals produced using
emerging technologies (e.g., genome editing) may meet applicable
statutory and regulatory requirements. FDA is issuing this draft
revised guidance for public comment consistent with this commitment in
the Strategy document. Under the Coordinated Framework for the

[[Page 6563]]

Regulation of Biotechnology, we intend to work cooperatively with other
relevant agencies that may also be considering their policies or
approaches related to genome editing applications within their
jurisdictions. As we finalize the draft revised guidance, we will be
consistent with the principles for the regulation of biotechnology
products articulated in the 2017 Update to the Coordinated Framework
(https://www.whitehouse.gov/sites/default/files/microsites/ostp/2017_coordinated_framework_update.pdf) and the goals and objectives of
the July 2015 EOP memorandum (https://www.whitehouse.gov/sites/default/files/microsites/ostp/modernizing_the_reg_system_for_biotech_products_memo_final.pdf).
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\1\ https://www.whitehouse.gov/sites/default/files/microsites/ostp/biotech_national_strategy_final.pdf.
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A. Key Draft Revisions

Draft revised GFI #187 is intended to clarify that, unless
otherwise excluded,\2\ the altered genomic DNA in an animal (referred
to in this document as ``animals with intentionally altered genomic
DNA'') that is intended to affect the structure or function of the body
of the animal or, in some cases, to diagnose, cure, mitigate, treat, or
prevent disease in the animal, meets the drug definition in section
201(g) of the FD&C Act. For the purposes of draft revised GFI #187,
``altered genomic DNA'' refers to the portion of an animal's genome
that has been intentionally altered. Such intentional alterations may
be made, for example, through the use of ``nucleases'' or ``genome
editing technologies,'' including engineered nuclease/nucleotide
complexes such as zinc finger nucleases (ZFN), transcription activator-
like effector nucleases (TALENs), and the clustered regulatory
interspersed short palindromic repeats (CRISPR) associated systems.
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\2\ In Draft Guidance for Industry #236, ``Regulation of
Mosquito-Related Products,'' FDA has proposed to clarify that the
phrase ``articles (other than food) intended to affect the structure
or any function of the body of man or other animals'' does not
include articles intended to prevent, destroy, repel, or mitigate
mosquitoes for population control purposes. Instead, such products
are pesticides regulated by the Environmental Protection Agency
(EPA) (http://www.fda.gov/downloads/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/UCM533600.pdf).
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Similar to current GFI #187, draft revised GFI #187 is intended to
clarify FDA's requirements and recommendations for producers and
developers of animals with intentionally altered genomic DNA. Current
GFI #187 and draft revised GFI #187 describe how the new animal drug
provisions of the FD&C Act apply with respect to the intentionally
altered genomic DNA of such animals.
Animals may have intentional genomic alterations that are heritable
or non-heritable (e.g., those alterations intended to be used as gene
therapy). Although much of draft revised GFI #187 is relevant to non-
heritable intentional genomic alterations, and FDA intends to regulate
non-heritable intentional genomic alterations in much the same way as
described in this draft revised guidance, this draft revised guidance
primarily addresses animals whose genomes have been intentionally
altered for heritable purposes.

B. Additional Issues for Consideration and Comment

FDA requests comment on draft revised GFI #187. In particular, we
request comments on two major categories of questions.
1. In the first, we seek the public's input on how to refer to
these animals. In the past, FDA has used the term ``genetically
engineered'' to refer to animals containing recombinant DNA constructs
intended to alter the structure or function of the body of the animal.
For this draft revised guidance, we have used the phrase ``animals
whose genomes have been altered intentionally.'' Other terms that could
be used include ``genome edited animals,'' ``intentionally altered
animals,'' or expanding the term ``genetically engineered'' to include
the deliberate modification of the characteristics of an organism by
manipulating its genetic material. The public is encouraged to suggest
other phrases that are accurate and inclusive.
2. The second set of questions for which we seek public input is on
whether there is any existing empirical evidence demonstrating that
certain types of genome editing may pose minimal risk, with particular
emphasis on the following:
a. Are there categories of animals whose genomes have been
intentionally altered for which specific empirical evidence indicates
that there are no significant target animal, user safety, food safety,
or environmental risks? If so, what is that evidence?
b. Are there categories of animals whose genomes have been
intentionally altered for which empirical evidence exists to
demonstrate that genome editing is durable on a genotypic and
phenotypic level and would continue to be durable over the lifetime of
a particular product? If so, what is that evidence?
c. Is there empirical evidence to demonstrate that there are
degrees of introduced changes (e.g., insertions or deletions of any
size or single nucleotide substitutions) that are likely to pose less
risk than other changes? If so, what is that evidence?
d. Is there empirical evidence that indicates that the degree of
taxonomic relationship between the introduced gene and the recipient
animal influences the health of that recipient animal or the extent to
which the trait is expressed? If so, what is that evidence?
We noted in current GFI #187 that we might issue a separate
guidance on the regulation of GE animals bearing non-heritable
alterations. Draft revised GFI #187 removes references to this and
other guidance documents that we intend to develop in the future. This
was not done to indicate that we no longer intend to issue such
guidance documents. In light of changing priorities over time, we may
issue other guidance documents before developing those identified in
current GFI #187, and therefore decided we should not indicate in the
text of the revised guidance any additional guidance documents that we
may develop in the future.
Current GFI #187 states, ``FDA is discussing with other agencies
the best approach for oversight of GE insects. Future guidance may be
developed to address them.'' Draft revised GFI #187 eliminates this
language. As indicated in the Strategy, FDA, EPA, and USDA intend to
``continue to examine their regulatory structures with the goal of
clarifying how the U.S. Federal Government will regulate genetically
engineered insects in an integrated and coordinated fashion to cover
the full range of potential products.'' FDA is continuing to work with
EPA and USDA, and will address this issue through action(s) separate
from this draft revision to current GFI #187. Elsewhere in this issue
of the Federal Register, we have published a notice announcing the
availability of a draft guidance for industry on regulation of
mosquito-related products.

II. Significance of Guidance

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
Regulation of Intentionally Altered Genomic DNA in Animals. 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.

[[Page 6564]]

III. Paperwork Reduction Act of 1995

This draft guidance refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information have been approved under OMB Control Nos.
0910-0032, 0910-0045, 0910-0117, and 0910-0284.

IV. Electronic Access

Persons with access to the Internet may obtain the draft guidance
at either http://www.fda.gov/AnimalVeterinary/GuidanceComplianceEnforcement/GuidanceforIndustry/default.htm or http://www.regulations.gov.

Dated: January 11, 2017.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2017-00839 Filed 1-18-17; 8:45 am]
BILLING CODE 4164-01-P

Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Notices 6561

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If you are representing an organization, The current list of states from which a Food and Drug Administration
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PowerPoint presentation, you will need Regulation of Intentionally Altered
enforcement-brief. We recommend that
to present the full disclosure Genomic DNA in Animals; Draft
confirmed registrants arrive reasonably
information requested previously at the Guidance for Industry; Availability
early, but no earlier than 45 minutes
beginning of your statement to the prior to the start of the meeting, to allow AGENCY: Food and Drug Administration,
Committee. additional time to clear security. HHS.
The Committee will deliberate openly Security measures include the ACTION: Notice of availability.
on the topics under consideration. following:
Interested persons may observe the • Presentation of government-issued SUMMARY: The Food and Drug
deliberations, but the Committee will photographic identification to the Administration (FDA or Agency) is
not hear further comments during this Federal Protective Service or Guard announcing the availability of a draft
time except at the request of the Service personnel. guidance for industry (GFI) #187
chairperson. The Committee will also • Inspection of vehicle’s interior and entitled ‘‘Regulation of Intentionally
mstockstill on DSK3G9T082PROD with NOTICES

allow a 15-minute unscheduled open exterior (this includes engine and trunk Altered Genomic DNA in Animals.’’
public session for any attendee to inspection) at the entrance to the This draft guidance revises GFI #187
address issues specific to the topics grounds. Parking permits and entitled ‘‘Regulation of Genetically
under consideration. At the conclusion instructions will be issued after the Engineered Animals Containing
of the day, the members will vote and vehicle inspection. Heritable Recombinant DNA
the Committee will make its • Inspection, via metal detector or Constructs’’ (current GFI #187). Current
recommendation(s) to CMS. other applicable means, of all persons GFI #187 clarifies FDA’s requirements

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Federal Register / Vol. 82, No. 12 / Thursday, January 19, 2017 / Notices 6563

Regulation of Biotechnology, we intend intentionally altered genomic DNA of deletions of any size or single
to work cooperatively with other such animals. nucleotide substitutions) that are likely
relevant agencies that may also be Animals may have intentional to pose less risk than other changes? If
considering their policies or approaches genomic alterations that are heritable or so, what is that evidence?
related to genome editing applications non-heritable (e.g., those alterations d. Is there empirical evidence that
within their jurisdictions. As we finalize intended to be used as gene therapy). indicates that the degree of taxonomic
the draft revised guidance, we will be Although much of draft revised GFI relationship between the introduced
consistent with the principles for the #187 is relevant to non-heritable gene and the recipient animal
regulation of biotechnology products intentional genomic alterations, and influences the health of that recipient
articulated in the 2017 Update to the FDA intends to regulate non-heritable animal or the extent to which the trait
Coordinated Framework (https:// intentional genomic alterations in much is expressed? If so, what is that
www.whitehouse.gov/sites/default/files/ the same way as described in this draft evidence?
microsites/ostp/2017_coordinated_ revised guidance, this draft revised We noted in current GFI #187 that we
framework_update.pdf) and the goals guidance primarily addresses animals might issue a separate guidance on the
and objectives of the July 2015 EOP whose genomes have been intentionally regulation of GE animals bearing non-
memorandum (https:// altered for heritable purposes. heritable alterations. Draft revised GFI
www.whitehouse.gov/sites/default/files/ B. Additional Issues for Consideration #187 removes references to this and
microsites/ostp/modernizing_the_reg_ and Comment other guidance documents that we
system_for_biotech_products_memo_ intend to develop in the future. This
final.pdf). FDA requests comment on draft
revised GFI #187. In particular, we was not done to indicate that we no
A. Key Draft Revisions request comments on two major longer intend to issue such guidance
categories of questions. documents. In light of changing
Draft revised GFI #187 is intended to priorities over time, we may issue other
clarify that, unless otherwise excluded,2 1. In the first, we seek the public’s
input on how to refer to these animals. guidance documents before developing
the altered genomic DNA in an animal those identified in current GFI #187,
(referred to in this document as In the past, FDA has used the term
‘‘genetically engineered’’ to refer to and therefore decided we should not
‘‘animals with intentionally altered indicate in the text of the revised
genomic DNA’’) that is intended to animals containing recombinant DNA
constructs intended to alter the guidance any additional guidance
affect the structure or function of the documents that we may develop in the
body of the animal or, in some cases, to structure or function of the body of the
animal. For this draft revised guidance, future.
diagnose, cure, mitigate, treat, or
we have used the phrase ‘‘animals Current GFI #187 states, ‘‘FDA is
prevent disease in the animal, meets the
whose genomes have been altered discussing with other agencies the best
drug definition in section 201(g) of the
intentionally.’’ Other terms that could approach for oversight of GE insects.
FD&C Act. For the purposes of draft
be used include ‘‘genome edited Future guidance may be developed to
revised GFI #187, ‘‘altered genomic
animals,’’ ‘‘intentionally altered address them.’’ Draft revised GFI #187
DNA’’ refers to the portion of an
animals,’’ or expanding the term eliminates this language. As indicated
animal’s genome that has been
‘‘genetically engineered’’ to include the in the Strategy, FDA, EPA, and USDA
intentionally altered. Such intentional
deliberate modification of the intend to ‘‘continue to examine their
alterations may be made, for example,
characteristics of an organism by regulatory structures with the goal of
through the use of ‘‘nucleases’’ or
manipulating its genetic material. The clarifying how the U.S. Federal
‘‘genome editing technologies,’’
public is encouraged to suggest other Government will regulate genetically
including engineered nuclease/
phrases that are accurate and inclusive. engineered insects in an integrated and
nucleotide complexes such as zinc
2. The second set of questions for coordinated fashion to cover the full
finger nucleases (ZFN), transcription
which we seek public input is on range of potential products.’’ FDA is
activator-like effector nucleases
whether there is any existing empirical continuing to work with EPA and
(TALENs), and the clustered regulatory
evidence demonstrating that certain USDA, and will address this issue
interspersed short palindromic repeats
types of genome editing may pose through action(s) separate from this
(CRISPR) associated systems.
Similar to current GFI #187, draft minimal risk, with particular emphasis draft revision to current GFI #187.
revised GFI #187 is intended to clarify on the following: Elsewhere in this issue of the Federal
FDA’s requirements and a. Are there categories of animals Register, we have published a notice
recommendations for producers and whose genomes have been intentionally announcing the availability of a draft
developers of animals with intentionally altered for which specific empirical guidance for industry on regulation of
altered genomic DNA. Current GFI #187 evidence indicates that there are no mosquito-related products.
and draft revised GFI #187 describe how significant target animal, user safety, II. Significance of Guidance
the new animal drug provisions of the food safety, or environmental risks? If
so, what is that evidence? This level 1 draft guidance is being
FD&C Act apply with respect to the
b. Are there categories of animals issued consistent with FDA’s good
2 In Draft Guidance for Industry #236, whose genomes have been intentionally guidance practices regulation (21 CFR
‘‘Regulation of Mosquito-Related Products,’’ FDA altered for which empirical evidence 10.115). The draft guidance, when
has proposed to clarify that the phrase ‘‘articles exists to demonstrate that genome finalized, will represent the current
(other than food) intended to affect the structure or editing is durable on a genotypic and thinking of FDA on Regulation of
mstockstill on DSK3G9T082PROD with NOTICES

any function of the body of man or other animals’’
does not include articles intended to prevent, phenotypic level and would continue to Intentionally Altered Genomic DNA in
destroy, repel, or mitigate mosquitoes for be durable over the lifetime of a Animals. It does not establish any rights
population control purposes. Instead, such products particular product? If so, what is that for any person and is not binding on
are pesticides regulated by the Environmental evidence? FDA or the public. You can use an
Protection Agency (EPA) (http://www.fda.gov/
downloads/AnimalVeterinary/Guidance
c. Is there empirical evidence to alternative approach if it satisfies the
ComplianceEnforcement/GuidanceforIndustry/ demonstrate that there are degrees of requirements of the applicable statutes
UCM533600.pdf). introduced changes (e.g., insertions or and regulations.

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Document Modified: 2018-02-01 15:15:20

Category		Regulatory Information
Collection		Federal Register
sudoc Class		AE 2.7: GS 4.107: AE 2.106:
Publisher		Office of the Federal Register, National Archives and Records Administration
Section		Notices
Action		Notice of availability.
Dates		Although you can comment on any guidance at any time (see 21 CFR 10.115(g)(5)), to ensure that the Agency considers your comment on this draft guidance before it begins work on the final version of the guidance, submit either electronic or written comments on the draft guidance by April 19, 2017.
Contact		Laura R. Epstein, Center for Veterinary Medicine (HFV-1), Food and Drug Administration, 7519 Standish Pl., Rockville, MD 20855, 301-796-8558, [email protected]
FR Citation		82 FR 6561

82 FR 6561 - Regulation of Intentionally Altered Genomic DNA in Animals; Draft Guidance for Industry; Availability

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration

Federal Register Volume 82, Issue 12 (January 19, 2017)

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration