[Federal Register Volume 89, Number 49 (Tuesday, March 12, 2024)]
[Notices]
[Pages 17854-17856]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-05219]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2024-N-0758]


Agency Information Collection Activities; Proposed Collection; 
Comment Request; 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 and 
consultations for new plant varieties intended for food use, including 
biotechnology-derived food plants.

DATES: Either electronic or written comments on the collection of 
information must be submitted by May 13, 2024.

ADDRESSES: You may submit comments as follows. Please note that late, 
untimely filed comments will not be considered. The https://www.regulations.gov electronic filing system will accept comments until 
11:59 p.m. Eastern Time at the end of May 13, 2024. Comments received 
by mail/hand delivery/courier (for written/paper submissions) will be 
considered timely if they are received 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-2024-N-0758 for ``Agency Information Collection Activities; 
Proposed Collection; Comment Request; 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

[[Page 17855]]

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.

New Plant Varieties Intended for Food Use

OMB Control Number 0910-0583--Extension

    This information collection supports recommendations found in FDA 
guidance pertaining to new plant varieties intended for food use.

I. Consultation Procedures: Foods Derived From New Plant Varieties; 
Form FDA 3665

    The Agency guidance document entitled ``Consultation Procedures 
under FDA's 1992 Statement of Policy for Foods Derived From New Plant 
Varieties'' (October 1997), which is available on our website at 
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-consultation-procedures-under-fdas-1992-statement-policy-foods-derived-new-plant, describes our consultation 
process for the evaluation of information on new plant varieties 
provided by developers. We believe 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 market entry decisions by the 
industry are made consistently and in full compliance with the 
standards of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
    Since 1992, when we issued our ``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 us 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. To 
initiate a New Plant Variety consultation (also known as a 
Biotechnology Notification File (BNF)), developers are encouraged to 
electronically submit their scientific information and data following a 
step-by-step process to complete Form FDA 3665, assemble their 
notification, and send fully electronic submissions to FDA via the 
Center for Food Safety and Applied Nutrition Online Submission Module 
(COSM), which may be accessed at https://www.fda.gov/food/registration-food-facilities-and-other-submissions/cfsan-online-submission-module-cosm. Firms that prefer to submit a paper notification in a paper 
format of their choosing or as electronic files on physical media with 
a paper signature page, have the option to do so; however, Form FDA 
3665 prompts a notifier to input the elements of a BNF in a standard 
format that we will be able to review efficiently. Form FDA 3665 may be 
accessed at https://www.fda.gov/about-fda/reports-manuals-forms/forms.

II. Early Food Safety Evaluation of New Non-Pesticidal Proteins 
Produced by New Plant Varieties Intended for Food Use; Form FDA 3666

    Since we issued the 1992 policy 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. The guidance, 
entitled ``Recommendations for the Early Food Safety Evaluation of New 
Non-Pesticidal Proteins Produced by New Plant Varieties Intended for 
Food Use'' (June 2006), which is available on our website at 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 biotechnology-derived food 
plants, and the procedures for communicating with us about the safety 
evaluation. To initiate an Early Food Safety Evaluation consultation 
(also known as a New Protein Consultation (NPC)), developers are 
encouraged to electronically submit their scientific information and 
data following a step-by-step process to complete Form FDA 3666, 
assemble their notification, and send fully electronic submissions to 
FDA via COSM, which may be accessed at https://www.fda.gov/food/registration-food-facilities-and-other-submissions/cfsan-online-submission-module-cosm. Firms that prefer to submit a paper NPC in a 
paper format of their choosing or as electronic files on physical media 
with a paper signature page, have the option to do so; however, Form 
FDA 3666 prompts a notifier to input the elements of an NPC in a 
standard format that we will be able to review efficiently. Form FDA 
3666 may be accessed at https://www.fda.gov/about-fda/reports-manuals-forms/forms.
    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:

[[Page 17856]]



                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                                   Number of       Total         Average
     Agency guidance recommendations; information collection         Form FDA      Number of    responses  per     annual      burden per    Total hours
                                                                       No.        respondents      respondent    responses      response
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                                             Consultation Procedures: Foods Derived From New Plant Varieties
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Initial consultation.............................................         None              30               2           60               4          240
Final consultation...............................................        3,665              12               1           12             150        1,800
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                    Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use
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Six data components..............................................        3,666               6               1            6              20          120
                                                                  --------------------------------------------------------------------------------------
    Total........................................................  ...........  ..............  ..............           78  ..............        2,160
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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 minor adjustments to update our 
burden estimate to reflect recent annual response rates (increased 
initial consultations under the New Plant Variety consultation 
procedures) and to clarify the total number of responses under the 
Early Food Safety Evaluation (NPC) procedures.

    Dated: March 7, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-05219 Filed 3-11-24; 8:45 am]
BILLING CODE 4164-01-P