[Federal Register Volume 80, Number 188 (Tuesday, September 29, 2015)]
[Notices]
[Pages 58487-58488]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-24620]


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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) 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, 2015.

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: FDA PRA Staff, Office of Operations, 
Food and Drug Administration, 8455 Colesville Rd., COLE-14526, Silver 
Spring, MD 20993-0002, [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 we issued a policy statement on foods 
derived from new plant varieties, we have encouraged developers of new 
plant varieties, including those varieties that are developed through 
biotechnology, 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 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. 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). 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, 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 a specific new protein produced by a new plant 
variety.
    In the Federal Register of June 19, 2015 (80 FR 35370), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.
    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:

                                                     Table 1--Estimated Annual Reporting Burden \1\
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                                                                                             Number of                        Average
                        Category                           FDA Form No.      Number of     responses per   Total annual     burden per      Total hours
                                                                            respondents     respondent       responses       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.

    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

[[Page 58488]]

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.
    For purposes of this extension request, we are re-evaluating our 
estimate of the annual number of responses that we expect to receive in 
the next 3 years. We received 12 NPCs during the 5-year period from 
2005 through 2009, for an average of 2.4 NPCs per year. However, during 
the last extension period, we saw a decrease in the number of NPCs 
submitted by developers, with no NPCs submitted in 2010 through 2014. 
More recently, we received four NPCs in the first 4 months of 2015. 
Based on an approximate average from the years 2005 through 2009, and 
our experience in 2015, we are revising our estimate of the annual 
number of NPCs submitted by developers to 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 
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 x 6 responses). Thus, we 
estimate the total annual hour burden for this collection of 
information to be 120 hours.

    Dated: September 23, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-24620 Filed 9-28-15; 8:45 am]
 BILLING CODE 4164-01-P