Food and Drug Administration, HHS.
The Food and Drug Administration (FDA or Agency) 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 of new non-pesticidal proteins produced by new plant varieties intended for food use, including bioengineered food plants.
Submit either electronic or written comments on the collection of information by July 24, 2018.
You may submit comments as follows. Please note that late, untimely filed comments will not be considered. Electronic comments must be submitted on or before July 24, 2018. The https://www.regulations.gov electronic filing system will accept comments until midnight Eastern Time at the end of July 24, 2018. Comments received by mail/hand delivery/courier (for written/paper submissions) will be considered timely if they are postmarked or the delivery service acceptance receipt is on or before that date.
Submit electronic comments in the following way:Start Printed Page 24316
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”).
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-2012-N-0438 for “Agency Information Collection Activities; Proposed Collection; Comment Request; Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by 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.
- 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.gpo.gov/fdsys/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.
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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.
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Under the PRA (44 U.S.C. 3501-3520), 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.
Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use
OMB Control Number 0910-0583—Extension
Since May 29, 1992, when FDA 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” continues to foster early communication by encouraging developers to submit to us their evaluation of the food safety of their new protein. 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 material from that plant variety.
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 in people or animals. 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 Start Printed Page 24317communicating with us about the safety evaluation.
Interested persons may use Form FDA 3666 to transmit their submissions to the Office of Food Additive Safety in the Center for Food Safety and Applied Nutrition. Form FDA 3666 is entitled “Early Food Safety Evaluation of a New Non-Pesticidal Protein Produced by a New Plant Variety (New Protein Consultation)” (https://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM350010.pdf) and may be used in lieu of a cover letter for a New Protein Consultation (NPC). Form FDA 3666 prompts a submitter to include certain elements of a 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 that would be prepared as attachments to the form, may be submitted in electronic format via the Electronic Submission Gateway (https://www.fda.gov/ForIndustry/ElectronicSubmissionsGateway/default.htm), paper format, or as electronic files on physical media with a paper signature page. FDA uses this information to evaluate the food safety of a specific new protein produced by a new plant variety.
Description of Respondents: The respondents to this collection of information are developers of new plant varieties intended for food use.
FDA estimates the burden of this collection of information as follows:
Table 1—Estimated Annual Reporting Burden 1
|Category||FDA Form No.||Number of respondents||Number of responses per
respondent||Total annual responses||Average burden per
|First four data components||3666||6||1||6||4||24|
|Two other data components||3666||6||1||6||16||96|
|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 no adjustments to our burden estimate. The estimated number of annual responses and average burden per response are based on our experience with early food safety evaluations. Completing an early food safety evaluation for a new protein from a new plant variety is a one-time burden (one evaluation per new protein). Many developers of novel plants may choose not to submit an evaluation because the field testing of a plant containing a new protein is conducted in such a way (e.g., on such a small scale, or in such isolated conditions, etc.) that cross-pollination with traditional crops or commingling of plant material is not likely to be an issue. Also, other developers may have previously communicated with us about the food safety of a new plant protein, for example, when the same protein was expressed in a different crop.
We estimate the annual number of NPCs submitted by developers will be six or fewer. The early food safety evaluation for new proteins includes six main data components. Four of these data components are easily and quickly obtainable, having to do with the identity and source of the protein. We estimate that completing these data components will take about 4 hours per NPC. We estimate the reporting burden for the first four data components to be 24 hours (4 hours × 6 responses).
Two data components ask for original data to be generated. One data component consists of a bioinformatics analysis that can be performed using publicly available databases. The other data component involves “wet” lab work to assess the new protein's stability and the resistance of the protein to enzymatic degradation using appropriate in vitro assays (protein digestibility study). The paperwork burden of these two data components consists of the time it takes the company to assemble the information on these two data components and include it in a NPC. We estimate that completing these data components will take about 16 hours per NPC. We estimate the reporting burden for the two other data components to be 96 hours (16 hours × 6 responses). Thus, we estimate the total annual burden for this collection of information to be 120 hours.
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Dated: May 9, 2018.
Associate Commissioner for Policy.
[FR Doc. 2018-11281 Filed 5-24-18; 8:45 am]
BILLING CODE 4164-01-P