Notice2024-16617
Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Plant Varieties Intended for Food Use
Primary source
Metadata and text below are from the Federal Register, a public-domain U.S. government work. Always verify the official published version before relying on it for any legal matter.
Published
July 29, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 145 (Monday, July 29, 2024)</title>
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[Federal Register Volume 89, Number 145 (Monday, July 29, 2024)]
[Notices]
[Pages 60900-60902]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.reginfo.gov/public/do/PRAMain">https://www.reginfo.gov/public/do/PRAMain</a>. 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,
<a href="/cdn-cgi/l/email-protection#ebbbb9aab89f8a8d8dab8d8f8ac5838398c58c849d"><span class="__cf_email__" data-cfemail="b2e2e0f3e1c6d3d4d4f2d4d6d39cdadac19cd5ddc4">[email protected]</span></a>.
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
<a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-consultation-procedures-under-fdas-1992-statement-policy-foods-derived-new-plant">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-consultation-procedures-under-fdas-1992-statement-policy-foods-derived-new-plant</a>, 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 <a href="https://www.fda.gov/food/registration-food-facilities-and-other-submissions/cfsan-online-submission-module-cosm">https://www.fda.gov/food/registration-food-facilities-and-other-submissions/cfsan-online-submission-module-cosm</a>. 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 <a href="https://www.fda.gov/about-fda/reports-manuals-forms/forms">https://www.fda.gov/about-fda/reports-manuals-forms/forms</a>.
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 <a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-recommendations-early-food-safety-evaluation-new-non-pesticidal-proteins-produced">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-recommendations-early-food-safety-evaluation-new-non-pesticidal-proteins-produced</a>, 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 <a href="https://www.fda.gov/food/registration-food-facilities-and-other-submissions/cfsan-online-submission-module-cosm">https://www.fda.gov/food/registration-food-facilities-and-other-submissions/cfsan-online-submission-module-cosm</a>. 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 <a href="https://www.fda.gov/about-fda/reports-manuals-forms/forms">https://www.fda.gov/about-fda/reports-manuals-forms/forms</a>.
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
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