Document ID: FDA-2020-N-1207-0004
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Submission for Office of Management and Budget Review; Comment Request; New Plant Varieties Intended for Food Use
Posted Date: 2021-06-30T04:00Z

[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, 
PRAStaff@fda.hhs.gov.

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