[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, [email protected].
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
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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.
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Dated: June 15, 2015.
Leslie Kux,
Associate Commissioner for Policy.
[FR Doc. 2015-15078 Filed 6-18-15; 8:45 am]
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