Agency Information Collection Activities; Proposed Collection; 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 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 https://www.regulations.gov 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:

• Federal eRulemaking Portal: https://www.regulations.gov. Follow the instructions for submitting comments. Comments submitted electronically, including attachments, to https://www.regulations.gov 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 https://www.regulations.gov.

• 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:

• 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.

• 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 https://www.regulations.gov or at the Dockets Management Staff between 9 a.m. and 4 p.m., Monday through Friday, 240–402–7500.

• 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 https://www.regulations.gov. 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: https://www.govinfo.gov/content/pkg/FR-2015-09-18/pdf/2015-23389.pdf.

Docket: For access to the docket to read background documents or the electronic and written/paper comments received, go to https://www.regulations.gov 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, PRAStaff@fda.hhs.gov.

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 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 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.

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 (NPC) procedures.