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) 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, 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—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 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:

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.