[Federal Register Volume 83, Number 189 (Friday, September 28, 2018)]
[Notices]
[Pages 49108-49109]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21148]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2012-N-0438]


Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Early Food Safety 
Evaluation of New Non-Pesticidal Proteins Produced by New Plant 
Varieties Intended for Food Use

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA 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: Fax written comments on the collection of information by October 
29, 2018.

ADDRESSES: To ensure that comments on the information collection are 
received, OMB recommends that written comments be faxed to the Office 
of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, 
Fax: 202-395-7285, or emailed to [email protected]. All 
comments should be identified with the OMB control number 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.

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,'' (available at https://www.fda.gov/Food/GuidanceRegulation/GuidanceDocumentsRegulatoryInformation/ucm096156.htm) 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 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 recommended 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. 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 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 that would be prepared as attachments to the form, may be 
submitted in electronic format via the Electronic Submission Gateway, 
or may be submitted in paper format, or as electronic files on physical 
media with paper signature page. The information is used by us to 
evaluate the food safety of

[[Page 49109]]

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.
    In the Federal Register of May 25, 2018 (83 FR 24315), we published 
a 60-day notice requesting public comment on the proposed collection of 
information. One comment was received but did not respond to any of the 
four information collection topics solicited and is therefore not 
addressed.
    We therefore estimate the burden for the information collection as 
follows:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                             Number of
                        Category                           Form FDA No.      Number of     responses per   Total annual   Average burden    Total hours
                                                                            respondents     respondent       responses     per response
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First four data components..............................            3666               6               1               6               4              24
Two other data components...............................            3666               6               1               6              16              96
                                                         -----------------------------------------------------------------------------------------------
    Total...............................................  ..............  ..............  ..............  ..............  ..............             120
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\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 x 6 
responses).
    Two data components ask for original data to be generated. One data 
component consists of a bioinformatics analysis which 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 
an 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 x 6 responses). Thus, we 
estimate the total annual hour burden for this collection of 
information to be 120 hours.

    Dated: September 25, 2018.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2018-21148 Filed 9-27-18; 8:45 am]
 BILLING CODE 4164-01-P