Agency Information Collection Activities; Proposed Collection; Comment Request; Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use, 12688-12690 [2021-04448]
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12688
Federal Register / Vol. 86, No. 41 / Thursday, March 4, 2021 / Notices
CDC or CBP may issue additional
operational guidance to aircraft
operators regarding the collection and
transmission of the designated
information, including for those who are
unable submit data in the manner
specified or to meet the deadline of
technical compliance.
Any airline that fails to comply with
section 1 may be subject to criminal
penalties under, inter alia, 42 U.S.C. 271
and 42 CFR 71.2, in conjunction with 18
U.S.C. 3559 and 3571.
2. This section applies to all other
aircraft operators not covered in section
1 above. Beginning 11:59 p.m. Eastern
Standard Time on March 4, 2021, for
each passenger flight transporting
passengers destined for the United
States from international last points of
departure who have been in DRC or
Guinea within 21 days prior to the date
of entry or attempted entry into the
United States, all airlines or aircraft
operators shall —
(a) Collect the designated information
for all passengers who are departing
from, or were otherwise present in, DRC
or Guinea within the 21 days prior to
their entry or attempted entry into the
United States. When collecting the
designated information, aircraft
operators shall notify passengers that
the obligation to provide the
information is a United States
Government requirement.
(b) Transmit the designated passenger
information to CBP or CDC through one
of the following means:
(1) Electronic Advance Passenger
Information System; 4 or
(2) Other means meeting minimum
standards deemed acceptable to CDC in
consultation with CBP.
(c) For all crew members, upon
request from the CDC Director, transmit
the designated information through
encrypted email or other means
approved by CDC within 24 hours.
CDC or CBP may issue additional
operational guidance to aircraft
operators regarding the collection and
transmission of the designated
information, including for those who are
unable submit data in the manner
specified or to meet the deadline of
technical compliance.
Any entities covered under section 2
that fail to comply with section 2 may
be subject to criminal penalties under,
inter alia, 42 U.S.C. 271 and 42 CFR
71.2, in conjunction with 18 U.S.C. 3559
and 3571.
3. Requirements for Passengers:
Beginning 11:59 p.m. Eastern
Standard Time on March 4, 2021, any
4 https://www.cbp.gov/travel/travel-industrypersonnel/apis/eapis-transmission-system
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passenger destined for the United States
on a flight covered under sections 1 or
2 who is departing from, or was
otherwise present in, DRC or Guinea
within 21 days prior to entry, or
attempted entry, into the United States
shall provide the designated
information, as instructed by the airline
or aircraft operator, insofar as the
information exists for the passenger.
Authorized representatives (for
example, immediate family member,
legal guardian, or travel agent) may
provide the designated information on
behalf of passengers, including on
behalf of minors or other passengers
who are unable to do so on their own
behalf), but the information must be
specific to the individual passenger
(e.g.agents may not put one number for
an entire group of unrelated persons).
Any passenger who fails to comply
with the requirements of section 3 may
be subject to criminal penalties under,
inter alia, 42 U.S.C. 271 and 42 CFR
71.2, in conjunction with 18 U.S.C. 3559
and 3571.
CDC and CBP will maintain the
designated information within their
respective systems in accordance with
Federal law, including the Privacy Act
of 1974 (5 U.S.C. 552a). Identifiable
information may be used and shared
only for lawful purposes, including with
authorized personnel of the United
States Department of Health and Human
Services; the United States Department
of Homeland Security; state, local,
tribal, and territorial public health
departments; and other cooperating
authorities, as authorized by law. CDC
and CBP will retain, use, delete, or
otherwise destroy the designated
information in accordance with the
Federal Records Act, applicable Privacy
Act System of Records Notices, and
other applicable law.
CDC may modify this Order by an
updated publication in the Federal
Register or by posting an advisory to
follow at www.cdc.gov.
Authority
The CDC Director is issuing this Order
pursuant to Sections 361 and 365 of the
Public Health Service (PHS) Act, 42
U.S.C. 264 and 268, and implementing
regulations at 42 CFR 71.4, 71.20, 71.31,
and 71.32.
Dated: March 2, 2021.
Sherri Berger,
Acting Chief of Staff, Centers for Disease
Control and Prevention.
[FR Doc. 2021–04625 Filed 3–2–21; 4:15 pm]
BILLING CODE 4163–18–P
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2012–N–0438]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Early Food Safety
Evaluation of New Non-Pesticidal
Proteins Produced by New Plant
Varieties Intended for Food Use
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 provisions of FDA’s
procedures for early food safety
evaluation of new non-pesticidal
proteins produced by new plant
varieties intended for food use,
including bioengineered food plants.
DATES: Submit either electronic or
written comments on the collection of
information by May 3, 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 May 3, 2021.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of May 3, 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
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
E:\FR\FM\04MRN1.SGM
04MRN1
Federal Register / Vol. 86, No. 41 / Thursday, March 4, 2021 / Notices
jbell on DSKJLSW7X2PROD with NOTICES
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–
2012–N–0438 for ‘‘Agency Information
Collection Activities; Proposed
Collection; Comment Request; Early
Food Safety Evaluation of New NonPesticidal Proteins Produced by New
Plant Varieties Intended for Food Use.’’
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
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20:27 Mar 03, 2021
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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.
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.
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
PO 00000
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12689
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.
Early Food Safety Evaluation of New
Non-Pesticidal Proteins Produced by
New Plant Varieties Intended for Food
Use
OMB Control Number 0910–0583—
Extension
This information collection supports
FDA regulations. Since May 29, 1992,
when we issued a policy statement on
foods derived from new plant varieties,
including those varieties that are
developed through biotechnology, we
have encouraged developers of new
plant varieties to consult with us early
in the development process to discuss
possible scientific and regulatory issues
that might arise (57 FR 22984). The
guidance, entitled ‘‘Recommendations
for the Early Food Safety Evaluation of
New Non-Pesticidal Proteins Produced
by New Plant Varieties Intended for
Food Use’’ (https://www.fda.gov/
regulatory-information/search-fdaguidance-documents/guidanceindustry-recommendations-early-foodsafety-evaluation-new-non-pesticidalproteins-produced), continues to foster
early communication by encouraging
developers to submit to us their
evaluation of the food safety of their
new proteins. Such communication
helps to ensure that any potential food
safety issues regarding a new protein in
a new plant variety are resolved early in
development, prior to any possible
inadvertent introduction into the food
supply of the new protein.
We believe that any food safety
concern related to such material
entering the food supply would be
limited to the potential that a new
protein in food from the plant variety
could cause an allergic reaction in
susceptible individuals or could be a
toxin. The guidance describes the
procedures for early food safety
evaluation of new proteins produced by
new plant varieties, including
bioengineered food plants, and the
procedures for communicating with us
about the safety evaluation.
Interested persons may use Form FDA
3666 to transmit their submission to the
Office of Food Additive Safety in the
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Federal Register / Vol. 86, No. 41 / Thursday, March 4, 2021 / Notices
Center for Food Safety and Applied
Nutrition (CFSAN). Form FDA 3666 is
entitled ‘‘Early Food Safety Evaluation
of a New Non-Pesticidal Protein
Produced by a New Plant Variety (New
Protein Consultation)’’ and may be used
in lieu of a cover letter for a New
Protein Consultation (NPC). The form
may be accessed at FDA’s web page for
forms (https://www.fda.gov/about-fda/
reports-manuals-forms/forms) using the
search term ‘‘3666.’’ To enable fieldfillable functionality of FDA forms, they
must be downloaded. Form FDA 3666
prompts a submitter to include certain
elements of an NPC in a standard format
and helps the respondent organize their
submission to focus on the information
needed for our safety review. The form,
and elements prepared as attachments
to the form, may be prepared using the
CFSAN Online Submission Module
(https://www.fda.gov/food/registrationfood-facilities-and-other-submissions/
cfsan-online-submission-module-cosm).
Once the submission is prepared, it may
be submitted in electronic format via the
Electronic Submissions Gateway
(https://www.fda.gov/industry/
electronic-submissions-gateway), paper
format, or as electronic files on physical
media with paper signature page. We
use this information to evaluate the food
safety of a specific new protein
produced by a new plant variety.
Description of Respondents: The
respondents to this collection of
information are 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
GFI section VI: Format for submission
Average
burden per
response
Total annual
responses
Total hours
First four data components ......................
Two other data components ....................
3666
3666
6
6
1
1
6
6
4
16
24
96
Total ..................................................
........................
........................
........................
........................
........................
120
1 There
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Number of
responses per
respondent
Number of
responses
Form FDA No.
are no capital costs or 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. The
estimated number of annual responses
and average burden per response are
based on our experience with early food
safety evaluations. Completing an early
food safety evaluation for a new protein
from a new plant variety is a one-time
burden (one evaluation per new
protein). Many developers of novel
plants may choose not to submit an
evaluation because the field testing of a
plant containing a new protein is
conducted in such a way (e.g., on such
a small scale, or in such isolated
conditions, etc.) that cross-pollination
with traditional crops or commingling
of plant material is not likely to be an
issue. Also, other developers may have
previously communicated with us about
the food safety of a new plant protein,
for example, when the same protein was
expressed in a different crop.
We estimate the annual number of
NPCs submitted by developers will be
six or fewer. The early food safety
evaluation for new proteins includes six
main data components. Four of these
data components, having to do with the
identity and source of the protein, are
easily and quickly obtainable. We
estimate that completing these data
components will take about 4 hours per
NPC.
Two data components ask for original
data to be generated. One data
component consists of a bioinformatics
analysis that can be performed using
publicly available databases. The other
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data component involves ‘‘wet’’ lab
work to assess the new protein’s
stability and the resistance of the
protein to enzymatic degradation using
appropriate in vitro assays (protein
digestibility study). The paperwork
burden of these two data components
consists of the time it takes the company
to assemble the information on these
two data components and include it in
an NPC. We estimate that completing
these data components will take about
16 hours per NPC.
Dated: February 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for
Policy.
[FR Doc. 2021–04448 Filed 3–3–21; 8:45 am]
BILLING CODE 4164–01–P
DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA–2009–N–0025]
Agency Information Collection
Activities; Proposed Collection;
Comment Request; Animal Food
Labeling; Declaration of Certified and
Non-Certified Color Additives
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Notice.
The Food and Drug
Administration (FDA or Agency) is
announcing an opportunity for public
comment on the proposed collection of
certain information by the Agency.
SUMMARY:
PO 00000
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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 provisions of FDA regulations
requiring the declaration of color
additives on animal food labels.
DATES: Submit either electronic or
written comments on the collection of
information by May 3, 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 May 3, 2021.
The https://www.regulations.gov
electronic filing system will accept
comments until 11:59 p.m. Eastern Time
at the end of May 3, 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
E:\FR\FM\04MRN1.SGM
04MRN1
]]>Agencies
[Federal Register Volume 86, Number 41 (Thursday, March 4, 2021)]
[Notices]
[Pages 12688-12690]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-04448]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2012-N-0438]
Agency Information Collection Activities; Proposed Collection;
Comment Request; Early Food Safety Evaluation of New Non-Pesticidal
Proteins Produced by New Plant Varieties Intended for Food Use
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
provisions of FDA's procedures for early food safety evaluation of new
non-pesticidal proteins produced by new plant varieties intended for
food use, including bioengineered food plants.
DATES: Submit either electronic or written comments on the collection
of information by May 3, 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 May 3, 2021. The https://www.regulations.gov electronic filing system will accept comments until
11:59 p.m. Eastern Time at the end of May 3, 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
[[Page 12689]]
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-2012-N-0438 for ``Agency Information Collection Activities;
Proposed Collection; Comment Request; Early Food Safety Evaluation of
New Non-Pesticidal Proteins Produced by New Plant Varieties Intended
for Food Use.'' 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.
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.
Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by
New Plant Varieties Intended for Food Use
OMB Control Number 0910-0583--Extension
This information collection supports FDA regulations. Since May 29,
1992, when we issued a policy statement on foods derived from new plant
varieties, including those varieties that are developed through
biotechnology, we have encouraged developers of new plant varieties to
consult with us early in the development process to discuss possible
scientific and regulatory issues that might arise (57 FR 22984). The
guidance, entitled ``Recommendations for the Early Food Safety
Evaluation of New Non-Pesticidal Proteins Produced by New Plant
Varieties Intended for Food Use'' (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-recommendations-early-food-safety-evaluation-new-non-pesticidal-proteins-produced), continues to foster early communication by
encouraging developers to submit to us their evaluation of the food
safety of their new proteins. Such communication helps to ensure that
any potential food safety issues regarding a new protein in a new plant
variety are resolved early in development, prior to any possible
inadvertent introduction into the food supply of the new protein.
We believe that any food safety concern related to such material
entering the food supply would be limited to the potential that a new
protein in food from the plant variety could cause an allergic reaction
in susceptible individuals or could be a toxin. The guidance describes
the procedures for early food safety evaluation of new proteins
produced by new plant varieties, including bioengineered food plants,
and the procedures for communicating with us about the safety
evaluation.
Interested persons may use Form FDA 3666 to transmit their
submission to the Office of Food Additive Safety in the
[[Page 12690]]
Center for Food Safety and Applied Nutrition (CFSAN). Form FDA 3666 is
entitled ``Early Food Safety Evaluation of a New Non-Pesticidal Protein
Produced by a New Plant Variety (New Protein Consultation)'' and may be
used in lieu of a cover letter for a New Protein Consultation (NPC).
The form may be accessed at FDA's web page for forms (https://www.fda.gov/about-fda/reports-manuals-forms/forms) using the search
term ``3666.'' To enable field-fillable functionality of FDA forms,
they must be downloaded. Form FDA 3666 prompts a submitter to include
certain elements of an NPC in a standard format and helps the
respondent organize their submission to focus on the information needed
for our safety review. The form, and elements prepared as attachments
to the form, may be prepared using the CFSAN Online Submission Module
(https://www.fda.gov/food/registration-food-facilities-and-other-submissions/cfsan-online-submission-module-cosm). Once the submission
is prepared, it may be submitted in electronic format via the
Electronic Submissions Gateway (https://www.fda.gov/industry/electronic-submissions-gateway), paper format, or as electronic files
on physical media with paper signature page. We use this information to
evaluate the food safety of a specific new protein produced by a new
plant variety.
Description of Respondents: The respondents to this collection of
information are 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 Average
GFI section VI: Format for submission Form FDA No. Number of responses per Total annual burden per Total hours
responses respondent responses response
--------------------------------------------------------------------------------------------------------------------------------------------------------
First four data components.............................. 3666 6 1 6 4 24
Two other data components............................... 3666 6 1 6 16 96
-----------------------------------------------------------------------------------------------
Total............................................... .............. .............. .............. .............. .............. 120
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\1\ There are no capital costs or 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. The estimated number of annual responses and average burden
per response are based on our experience with early food safety
evaluations. Completing an early food safety evaluation for a new
protein from a new plant variety is a one-time burden (one evaluation
per new protein). Many developers of novel plants may choose not to
submit an evaluation because the field testing of a plant containing a
new protein is conducted in such a way (e.g., on such a small scale, or
in such isolated conditions, etc.) that cross-pollination with
traditional crops or commingling of plant material is not likely to be
an issue. Also, other developers may have previously communicated with
us about the food safety of a new plant protein, for example, when the
same protein was expressed in a different crop.
We estimate the annual number of NPCs submitted by developers will
be six or fewer. The early food safety evaluation for new proteins
includes six main data components. Four of these data components,
having to do with the identity and source of the protein, are easily
and quickly obtainable. We estimate that completing these data
components will take about 4 hours per NPC.
Two data components ask for original data to be generated. One data
component consists of a bioinformatics analysis that can be performed
using publicly available databases. The other data component involves
``wet'' lab work to assess the new protein's stability and the
resistance of the protein to enzymatic degradation using appropriate in
vitro assays (protein digestibility study). The paperwork burden of
these two data components consists of the time it takes the company to
assemble the information on these two data components and include it in
an NPC. We estimate that completing these data components will take
about 16 hours per NPC.
Dated: February 26, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-04448 Filed 3-3-21; 8:45 am]
BILLING CODE 4164-01-P
