[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]


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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.

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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

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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
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First four data components..............................            3666               6               1               6               4              24
Two other data components...............................            3666               6               1               6              16              96
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    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