Document ID: FDA-2012-N-0438-0003
Agency: fda
Document Type: Notice
Title: 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
Posted Date: 2015-06-19T04:00Z

[Federal Register Volume 80, Number 118 (Friday, June 19, 2015)]
[Notices]
[Pages 35370-35372]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2015-15078]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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

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

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing an 
opportunity for public comment on the proposed collection of certain 
information by the Agency. Under the Paperwork Reduction Act of 1995 
(the PRA), Federal Agencies must publish a notice in the Federal 
Register concerning each proposed collection of information, including 
each proposed extension of an existing collection of information, and 
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.

DATES: Submit either electronic or written comments on the collection 
of information by August 18, 2015.

ADDRESSES: Submit electronic comments on the collection of information 
to http://www.regulations.gov. Submit written comments on the 
collection of information to the Division of Dockets Management (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, 
Rockville, MD 20852. All comments should be identified with the 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, PRAStaff@fda.hhs.gov.

SUPPLEMENTARY INFORMATION: 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, we are publishing this notice of the proposed 
collection of information set forth in this document.
    With respect to the following collection of information, we invite 
comments on these topics: (1) Whether the proposed collection of 
information is necessary for the proper performance of our functions, 
including whether the information will have practical utility; (2) the 
accuracy of our estimate of the

[[Page 35371]]

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 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.
    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
                Category                        FDA Form No.            Number of      responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
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First four data components.............  Form FDA 3666.............               6                1                6                4               24
Two other data components..............  Form FDA 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 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 4 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 6 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.

[[Page 35372]]

    Dated: June 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-15078 Filed 6-18-15; 8:45 am]
 BILLING CODE 4164-01-P