[Federal Register Volume 86, Number 123 (Wednesday, June 30, 2021)]
[Notices]
[Pages 34765-34767]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2021-13953]
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. FDA-2020-N-1207]
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.
-----------------------------------------------------------------------
SUMMARY: The Food and Drug Administration (FDA, Agency, or we) 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 July 30, 2021.
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--Revision
This information collection supports recommendations found in
Agency guidance pertaining to new plant varieties intended for food
use. Respondents to the collection of information are developers of new
plant varieties intended for food use.
[[Page 34766]]
I. Consultation Procedures: Foods Derived From New Plant Varieties;
Form FDA 3665
The Agency guidance document entitled ``Guidance on Consultation
Procedures: Foods Derived From New Plant Varieties,'' which is
available on our website at https://www.fda.gov/FoodGuidances,
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
all 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 FDA issued its ``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 FDA 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 (57 FR
22984 at 22985). Respondents may use Form FDA 3665, submitted via the
Electronic Submissions Gateway (https://www.fda.gov/industry/electronic-submissions-gateway), to request consultation.
II. Early Food Safety Evaluation of New Non-Pesticidal Proteins
Produced by New Plant Varieties Intended for Food Use; Form FDA 3666
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 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.
In the Federal Register of November 23, 2020 (85 FR 74734), we
published a 60-day notice requesting public comment on information
collection associated with the guidance document ``Recommendations for
the Early Food Safety Evaluation of New Non-Pesticidal Proteins
Produced by New Plant Varieties Intended for Food Use.'' No comments
were received.
In the Federal Register of March 4, 2021 (86 FR 12688), we
published a 60-day notice requesting public comment on information
collection associated with the guidance document ``Early Food Safety
Evaluation of New Non-Pesticidal Proteins Produced by New Plant
Varieties Intended for Food Use.'' No comments were received.
We estimate the burden of the information collection as follows:
Table 1--Estimated Annual Reporting Burden 1
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of
Agency guidance recommendations; information collection Form FDA No. Number of responses per Total annual Average burden Total hours
responses respondent responses per response
--------------------------------------------------------------------------------------------------------------------------------------------------------
Consultation Procedures: Foods Derived From New Plant Varieties
--------------------------------------------------------------------------------------------------------------------------------------------------------
Initial consultation.................................... None 20 2 40 4 160
Final consultation...................................... 3665 12 1 12 150 1,800
--------------------------------------------------------------------------------------------------------------------------------------------------------
Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use
--------------------------------------------------------------------------------------------------------------------------------------------------------
First four data components.............................. 3666 6 1 6 4 24
Two other data components............................... 3666 6 1 6 16 96
-----------------------------------------------------------------------------------------------
[[Page 34767]]
Total............................................... .............. .............. .............. 64 .............. 2,080
--------------------------------------------------------------------------------------------------------------------------------------------------------
1There are no capital costs or operating and maintenance costs associated with this collection of information.
For efficiency of Agency operations, we are consolidating these
related information collections. We retain our estimate of burden
associated with the individual collection activities but have increased
burden in OMB control number 0910-0583 by 52 responses and 1,960 hours
annually to reflect the reorganization of the information collection.
Upon OMB approval of our request, we intend to discontinue OMB control
number 0910-0704.
Dated: June 24, 2021.
Lauren K. Roth,
Acting Principal Associate Commissioner for Policy.
[FR Doc. 2021-13953 Filed 6-29-21; 8:45 am]
BILLING CODE 4164-01-P