Agency Information Collection Activities; Proposed Collection; Comment Request; Consultation Procedures: Foods Derived From New Plant Varieties, 74734-74736 [2020-25752]
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Federal Register / Vol. 85, No. 226 / Monday, November 23, 2020 / Notices
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2017–N–6455]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Consultation
Procedures: Foods Derived From New
Plant Varieties
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA, Agency, or we) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
Under the Paperwork Reduction Act of
1995 (PRA), Federal Agencies are
required to publish notice in the
Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information, and
to allow 60 days for public comment in
response to the notice. This notice
solicits comments on the information
collection pertaining to FDA
consultation procedures for foods
derived from new plant varieties,
including information collection
provisions in the guidance entitled,
‘‘Guidance on Consultation Procedures:
Foods Derived From New Plant
Varieties,’’ and in Form FDA 3665
entitled, ‘‘Final Consultation For Food
Derived From a New Plant Variety
(Biotechnology Final Consultation),’’
which developers may use to prepare
the final consultation in a standard
format.
DATES: Submit either electronic or
written comments on the collection of
information by January 22, 2021.
ADDRESSES: You may submit comments
as follows. Please note that late,
untimely filed comments will not be
considered. Electronic comments must
be submitted on or before January 22,
2021. The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of January 22, 2021.
Comments received by mail/hand
delivery/courier (for written/paper
submissions) will be considered timely
if they are postmarked or the delivery
service acceptance receipt is on or
before that date.
SUMMARY:
Electronic Submissions
Submit electronic comments in the
following way:
• Federal eRulemaking Portal:
https://www.regulations.gov. Follow the
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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–
2017–N–6455 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request;
Consultation Procedures: Foods Derived
From New Plant Varieties.’’ Received
comments, those filed in a timely
manner (see ADDRESSES), 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
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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.
FOR FURTHER INFORMATION CONTACT:
Domini Bean, Office of Operations,
Food and Drug Administration, Three
White Flint North, 10A–12M, 11601
Landsdown St., North Bethesda, MD
20852, 301–796–5733, PRAStaff@
fda.hhs.gov.
Under the
PRA (44 U.S.C. 3501–3521), Federal
Agencies must obtain approval from the
Office of Management and Budget
(OMB) for each collection of
information they conduct or sponsor.
‘‘Collection of information’’ is defined
in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests
or requirements that members of the
public submit reports, keep records, or
provide information to a third party.
Section 3506(c)(2)(A) of the PRA (44
U.S.C. 3506(c)(2)(A)) requires Federal
Agencies to provide a 60-day notice in
the Federal Register concerning each
proposed collection of information,
including each proposed extension of an
existing collection of information,
before submitting the collection to OMB
for approval. To comply with this
requirement, FDA is publishing notice
of the proposed collection of
information set forth in this document.
SUPPLEMENTARY INFORMATION:
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Federal Register / Vol. 85, No. 226 / Monday, November 23, 2020 / Notices
With respect to the following
collection of information, FDA invites
comments on these topics: (1) Whether
the proposed collection of information
is necessary for the proper performance
of FDA’s functions, including whether
the information will have practical
utility; (2) the accuracy of FDA’s
estimate of the burden of the proposed
collection of information, including the
validity of the methodology and
assumptions used; (3) ways to enhance
the quality, utility, and clarity of the
information to be collected; and (4)
ways to minimize the burden of the
collection of information on
respondents, including through the use
of automated collection techniques,
when appropriate, and other forms of
information technology.
Consultation Procedures: Foods
Derived From New Plant Varieties
OMB Control Number 0910–0704—
Extension
This information collection supports
FDA’s consultation procedures for foods
derived from new plant varieties, as
discussed and included in Agency
guidance, and in Form FDA 3665. We
recommend that producers who use
biotechnology in the manufacture or
development of foods and food
ingredients work cooperatively with
FDA to ensure that products derived
through biotechnology are safe and
comply with all applicable legal
requirements and have instituted a
voluntary consultation process with
industry. To facilitate this process, the
Agency issued a guidance entitled,
‘‘Guidance on Consultation Procedures:
Foods Derived From New Plant
Varieties,’’ which is available on our
website at https://www.fda.gov/
FoodGuidances. The guidance describes
FDA’s consultation process for the
evaluation of information on new plant
varieties provided by developers. The
Agency believes this consultation
process will help ensure that human
and animal food safety issues or other
regulatory issues (e.g., labeling) are
resolved prior to commercial
distribution. Additionally, such
communication will help to ensure that
any potential food safety issues
regarding a new plant variety are
resolved during development and will
help to ensure that all market entry
decisions by the industry are made
consistently and in full compliance with
the standards of the Federal Food, Drug,
and Cosmetic Act (the FD&C Act).
Since 1992, when FDA issued its
‘‘Statement of Policy: Foods Derived
From New Plant Varieties’’ (the 1992
policy) (57 FR 22984, May 29, 1992), we
have encouraged developers of new
plant varieties, including those varieties
that are developed through
biotechnology, to consult with FDA
during the plant development process to
discuss possible scientific and
regulatory issues that might arise. In the
1992 policy, we explained that under
the FD&C Act developers of new foods
(in this document food refers to both
human and animal food) have a
responsibility to ensure that the foods
they offer to consumers are safe and in
compliance with all requirements of the
FD&C Act (57 FR 22984 at 22985).
Description of Respondents:
Respondents to this collection of
information include developers of new
plant varieties intended for food use.
We estimate the burden of this
collection of information as follows:
TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1
Form FDA
No.
Activity
Number of
respondents
Number of
responses per
respondent
Average
burden per
response
Total annual
responses
Total hours
Initial consultation ....................................
Final consultation .....................................
None
3665
20
12
2
1
40
12
4
150
160
1,800
Total ..................................................
........................
........................
........................
........................
........................
1,960
1 There
are no operating and maintenance costs associated with this collection of information.
Based on a review of the information
collection since our last request for
OMB approval, we have made no
adjustments to our burden estimate.
Initial Consultations
Initial consultations are generally a
one-time burden, although a developer
might return more than once to discuss
additional issues before submitting a
final consultation. As noted in the
guidance, we encourage developers to
consult early in the development phase
of their products, and as often as
necessary. Historically, firms
developing a new genetically
engineered plant variety intended for
food use have generally initiated
consultation with FDA early in the
process of developing such a variety,
even though there is no legal obligation
for such consultation. These
consultations have made FDA aware of
foods and food ingredients before these
products are distributed commercially
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and have provided FDA with the
information necessary to address any
potential questions regarding the safety,
labeling, or regulatory status of the food
or food ingredient. As such, these
consultations have aided both industry
and the Agency in exercising their
mutual responsibilities under the FD&C
Act.
We estimate that the Center for
Veterinary Medicine and the Center for
Food Safety and Applied Nutrition
jointly received an average of 40
requests for initial consultations per
year in the last 3 years via email, or
written letter. Based on this
information, we expect to receive no
more than 40 annually for a total of 160
hours for initial consultations.
Final Consultations
Final consultations are a one-time
burden. At some stage in the process of
research and development, a developer
will have accumulated the information
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that the developer believes is adequate
to ensure that food derived from the
new plant variety is safe and that it
demonstrates compliance with the
relevant provisions of the FD&C Act.
The developer will then be able to
conclude any ongoing consultation with
FDA. The developer submits to FDA a
summary of the safety and nutritional
assessment that has been conducted
about the genetically engineered food
intended to be introduced into
commercial distribution. We evaluate
the submission to ensure that all
potential safety and regulatory questions
have been addressed. We have
developed a form that prompts a
developer to include certain elements in
the final consultation in a standard
format: Form FDA 3665 entitled, ‘‘Final
Consultation for Food Derived From a
New Plant Variety (Biotechnology Final
Consultation).’’ The form and its
elements that would be prepared as
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Federal Register / Vol. 85, No. 226 / Monday, November 23, 2020 / Notices
attachments to the form can be
submitted in electronic format.
We base our estimate of the average
time to prepare a submission on
informal contact with firms that made
one or more biotechnology consultation
submission under the voluntary
biotechnology consultation process. We
estimate the average time to prepare a
submission for final consultation to be
150 hours. With an estimated 12 annual
submissions, the total will be 1,800
hours for final consultations.
The total estimated burden for this
collection of information is 1,960 hours.
Dated: November 16, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2020–25752 Filed 11–20–20; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2018–D–0943]
Elemental Impurities in Animal Drug
Products—Questions and Answers;
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 #255 entitled
‘‘Elemental Impurities in Animal Drug
Products—Questions and Answers.’’
This guidance provides
recommendations to sponsors regarding
the control of elemental impurities in
animal drug products, including all
dosage forms and routes of
administration.
SUMMARY:
The announcement of the
guidance is published in the Federal
Register on November 23, 2020.
ADDRESSES: You may submit either
electronic or written comments on
Agency guidances at any time as
follows:
DATES:
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
VerDate Sep<11>2014
17:07 Nov 20, 2020
Jkt 253001
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–
2018–D–0943 for ‘‘Elemental Impurities
in Animal Drug Products—Questions
and Answers.’’ 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
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Sfmt 4703
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 guidance
document.
FOR FURTHER INFORMATION CONTACT:
Michael Brent, Center for Veterinary
Medicine (HFV–140), Food and Drug
Administration, 7500 Standish Pl.,
Rockville, MD 20855, 240–402–0647,
michael.brent@fda.hhs.gov or
AskCVM@fda.hhs.gov.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of March 27,
2018 (83 FR 13134), FDA published the
notice of availability for a draft guidance
entitled ‘‘Elemental Impurities in
Animal Drug Products—Questions and
Answers,’’ giving interested persons
until May 29, 2018, to comment on the
draft guidance. On August 15, 2018, we
published a notice reopening the
comment period to October 15, 2018 (83
FR 40524). FDA received comments on
the draft guidance, and those comments
were considered as the guidance was
finalized. The guidance announced in
this notice finalizes the draft guidance
dated March 2018.
This level 1 guidance is being issued
consistent with FDA’s good guidance
E:\FR\FM\23NON1.SGM
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]]>Agencies
[Federal Register Volume 85, Number 226 (Monday, November 23, 2020)]
[Notices]
[Pages 74734-74736]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-25752]
[[Page 74734]]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2017-N-6455]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Consultation Procedures: Foods Derived From New Plant
Varieties
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) is
announcing an opportunity for public comment on the proposed collection
of certain information by the Agency. Under the Paperwork Reduction Act
of 1995 (PRA), Federal Agencies are required to publish notice in the
Federal Register concerning each proposed collection of information,
including each proposed extension of an existing collection of
information, and to allow 60 days for public comment in response to the
notice. This notice solicits comments on the information collection
pertaining to FDA consultation procedures for foods derived from new
plant varieties, including information collection provisions in the
guidance entitled, ``Guidance on Consultation Procedures: Foods Derived
From New Plant Varieties,'' and in Form FDA 3665 entitled, ``Final
Consultation For Food Derived From a New Plant Variety (Biotechnology
Final Consultation),'' which developers may use to prepare the final
consultation in a standard format.
DATES: Submit either electronic or written comments on the collection
of information by January 22, 2021.
ADDRESSES: You may submit comments as follows. Please note that late,
untimely filed comments will not be considered. Electronic comments
must be submitted on or before January 22, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of January 22, 2021. Comments
received by mail/hand delivery/courier (for written/paper submissions)
will be considered timely if they are postmarked or the delivery
service acceptance receipt is on or before that date.
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-2017-N-6455 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Consultation Procedures: Foods
Derived From New Plant Varieties.'' Received comments, those filed in a
timely manner (see ADDRESSES), 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.
FOR FURTHER INFORMATION CONTACT: Domini Bean, Office of Operations,
Food and Drug Administration, Three White Flint North, 10A-12M, 11601
Landsdown St., North Bethesda, MD 20852, 301-796-5733,
[email protected].
SUPPLEMENTARY INFORMATION: Under the PRA (44 U.S.C. 3501-3521), Federal
Agencies must obtain approval from the Office of Management and Budget
(OMB) for each collection of information they conduct or sponsor.
``Collection of information'' is defined in 44 U.S.C. 3502(3) and 5 CFR
1320.3(c) and includes Agency requests or requirements that members of
the public submit reports, keep records, or provide information to a
third party. Section 3506(c)(2)(A) of the PRA (44 U.S.C. 3506(c)(2)(A))
requires Federal Agencies to provide a 60-day notice in the Federal
Register concerning each proposed collection of information, including
each proposed extension of an existing collection of information,
before submitting the collection to OMB for approval. To comply with
this requirement, FDA is publishing notice of the proposed collection
of information set forth in this document.
[[Page 74735]]
With respect to the following collection of information, FDA
invites comments on these topics: (1) Whether the proposed collection
of information is necessary for the proper performance of FDA's
functions, including whether the information will have practical
utility; (2) the accuracy of FDA's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (3) ways to enhance the quality,
utility, and clarity of the information to be collected; and (4) ways
to minimize the burden of the collection of information on respondents,
including through the use of automated collection techniques, when
appropriate, and other forms of information technology.
Consultation Procedures: Foods Derived From New Plant Varieties
OMB Control Number 0910-0704--Extension
This information collection supports FDA's consultation procedures
for foods derived from new plant varieties, as discussed and included
in Agency guidance, and in Form FDA 3665. We recommend that producers
who use biotechnology in the manufacture or development of foods and
food ingredients work cooperatively with FDA to ensure that products
derived through biotechnology are safe and comply with all applicable
legal requirements and have instituted a voluntary consultation process
with industry. To facilitate this process, the Agency issued a guidance
entitled, ``Guidance on Consultation Procedures: Foods Derived From New
Plant Varieties,'' which is available on our website at https://www.fda.gov/FoodGuidances. The guidance describes FDA's consultation
process for the evaluation of information on new plant varieties
provided by developers. The Agency believes this consultation process
will help ensure that human and animal food safety issues or other
regulatory issues (e.g., labeling) are resolved prior to commercial
distribution. Additionally, such communication will help to ensure that
any potential food safety issues regarding a new plant variety are
resolved during development and will help to ensure that all market
entry decisions by the industry are made consistently and in full
compliance with the standards of the Federal Food, Drug, and Cosmetic
Act (the FD&C Act).
Since 1992, when FDA issued its ``Statement of Policy: Foods
Derived From New Plant Varieties'' (the 1992 policy) (57 FR 22984, May
29, 1992), we have encouraged developers of new plant varieties,
including those varieties that are developed through biotechnology, to
consult with FDA during the plant development process to discuss
possible scientific and regulatory issues that might arise. In the 1992
policy, we explained that under the FD&C Act developers of new foods
(in this document food refers to both human and animal food) have a
responsibility to ensure that the foods they offer to consumers are
safe and in compliance with all requirements of the FD&C Act (57 FR
22984 at 22985).
Description of Respondents: Respondents to this collection of
information include developers of new plant varieties intended for food
use.
We estimate the burden of this collection of information as
follows:
Table 1--Estimated Annual Reporting Burden \1\
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Number of
Activity Form FDA No. Number of responses per Total annual Average burden Total hours
respondents respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Initial consultation.................................... None 20 2 40 4 160
Final consultation...................................... 3665 12 1 12 150 1,800
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Total............................................... .............. .............. .............. .............. .............. 1,960
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\1\ There are no operating and maintenance costs associated with this collection of information.
Based on a review of the information collection since our last
request for OMB approval, we have made no adjustments to our burden
estimate.
Initial Consultations
Initial consultations are generally a one-time burden, although a
developer might return more than once to discuss additional issues
before submitting a final consultation. As noted in the guidance, we
encourage developers to consult early in the development phase of their
products, and as often as necessary. Historically, firms developing a
new genetically engineered plant variety intended for food use have
generally initiated consultation with FDA early in the process of
developing such a variety, even though there is no legal obligation for
such consultation. These consultations have made FDA aware of foods and
food ingredients before these products are distributed commercially and
have provided FDA with the information necessary to address any
potential questions regarding the safety, labeling, or regulatory
status of the food or food ingredient. As such, these consultations
have aided both industry and the Agency in exercising their mutual
responsibilities under the FD&C Act.
We estimate that the Center for Veterinary Medicine and the Center
for Food Safety and Applied Nutrition jointly received an average of 40
requests for initial consultations per year in the last 3 years via
email, or written letter. Based on this information, we expect to
receive no more than 40 annually for a total of 160 hours for initial
consultations.
Final Consultations
Final consultations are a one-time burden. At some stage in the
process of research and development, a developer will have accumulated
the information that the developer believes is adequate to ensure that
food derived from the new plant variety is safe and that it
demonstrates compliance with the relevant provisions of the FD&C Act.
The developer will then be able to conclude any ongoing consultation
with FDA. The developer submits to FDA a summary of the safety and
nutritional assessment that has been conducted about the genetically
engineered food intended to be introduced into commercial distribution.
We evaluate the submission to ensure that all potential safety and
regulatory questions have been addressed. We have developed a form that
prompts a developer to include certain elements in the final
consultation in a standard format: Form FDA 3665 entitled, ``Final
Consultation for Food Derived From a New Plant Variety (Biotechnology
Final Consultation).'' The form and its elements that would be prepared
as
[[Page 74736]]
attachments to the form can be submitted in electronic format.
We base our estimate of the average time to prepare a submission on
informal contact with firms that made one or more biotechnology
consultation submission under the voluntary biotechnology consultation
process. We estimate the average time to prepare a submission for final
consultation to be 150 hours. With an estimated 12 annual submissions,
the total will be 1,800 hours for final consultations.
The total estimated burden for this collection of information is
1,960 hours.
Dated: November 16, 2020.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2020-25752 Filed 11-20-20; 8:45 am]
BILLING CODE 4164-01-P
