[Federal Register Volume 89, Number 145 (Monday, July 29, 2024)]
[Notices]
[Pages 60900-60902]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-16617]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; 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) is announcing that a 
proposed collection of information has been submitted to the Office of 
Management and Budget (OMB) for review and clearance under the 
Paperwork Reduction Act of 1995.

DATES: Submit written comments (including recommendations) on the 
collection of information by August 28, 2024.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be submitted to https://www.reginfo.gov/public/do/PRAMain. Find this particular information 
collection by selecting ``Currently under Review--Open for Public 
Comments'' or by using the search function. The OMB control number for 
this information collection is 0910-0583. Also include the FDA docket 
number found in brackets in the heading of this document.

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: In compliance with 44 U.S.C. 3507, FDA has 
submitted the following proposed collection of information to OMB for 
review and clearance.

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

[[Page 60901]]

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.
    In the Federal Register of March 12, 2024 (89 FR 17854), we 
published a 60-day notice soliciting comment on the proposed collection 
of information. Several comments were received. Most comments indicated 
that the information collected was necessary and had practical utility 
which allows FDA to make decisions regarding food safety and protection 
of the public's health. Some of the comments also indicated that the 
use of automation such as electronic forms made the process of 
submitting information much quicker and smoother for the respondent. 
Two comments received were not related to the PRA and are therefore not 
discussed. No adjustments to our burden estimates were made in response 
to the public comments.
    We estimate the burden of this collection of information as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                             Number of
 Agency guidance recommendations; information collection   Form FDA No.      Number of     responses per   Total annual   Average burden    Total hours
                                                                            respondents     respondent       responses     per 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
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    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 procedures.


[[Page 60902]]


    Dated: July 24, 2024.
Lauren K. Roth,
Associate Commissioner for Policy.
[FR Doc. 2024-16617 Filed 7-26-24; 8:45 am]
BILLING CODE 4164-01-P