Notice2024-05219
Agency Information Collection Activities; Proposed Collection; Comment Request; New Plant Varieties Intended for Food Use
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Published
March 12, 2024
Issuing agencies
Health and Human Services DepartmentFood and Drug Administration
Abstract
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.
Full Text
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<title>Federal Register, Volume 89 Issue 49 (Tuesday, March 12, 2024)</title>
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[Federal Register Volume 89, Number 49 (Tuesday, March 12, 2024)]
[Notices]
[Pages 17854-17856]
From the Federal Register Online via the Government Publishing Office [<a href="http://www.gpo.gov">www.gpo.gov</a>]
[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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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:
<bullet> Federal eRulemaking Portal: <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
Follow the instructions for submitting comments. Comments submitted
electronically, including attachments, to <a href="https://www.regulations.gov">https://www.regulations.gov</a>
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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
<bullet> 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:
<bullet> 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.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a> or at the Dockets Management Staff between 9 a.m.
and 4 p.m., Monday through Friday, 240-402-7500.
<bullet> 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 <a href="https://www.regulations.gov">https://www.regulations.gov</a>.
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: <a href="https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf">https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf</a>.
Docket: For access to the docket to read background documents or
the electronic and written/paper comments received, go to <a href="https://www.regulations.gov">https://www.regulations.gov</a> 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,
<a href="/cdn-cgi/l/email-protection#f1a1a3b0a285909797b1979590df999982df969e87"><span class="__cf_email__" data-cfemail="87d7d5c6d4f3e6e1e1c7e1e3e6a9efeff4a9e0e8f1">[email protected]</span></a>.
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
<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 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.
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
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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 (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
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