
[Federal Register Volume 77, Number 94 (Tuesday, May 15, 2012)]
[Notices]
[Pages 28602-28604]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-11689]


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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 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; new Form FDA 3666, which 
may be submitted electronically via the Electronic Submission Gateway 
(ESG); and the guidance document entitled, ``Recommendations for the 
Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by 
New Plant Varieties Intended for Food Use.''

DATES: Submit either electronic or written comments on the collection 
of information by July 16, 2012.

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: Domini Bean, Office of Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400T, 
Rockville, MD 20850, 301-796-5733, domini.bean@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, 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)--Revision

I. Background

    Since May 29, 1992, when FDA issued a policy statement on foods 
derived from new plant varieties, FDA has encouraged developers of new 
plant varieties, including those varieties that are developed through 
biotechnology, to consult with FDA 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 FDA 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.
    FDA believes 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 in new 
plant varieties, including bioengineered food plants, and the 
procedures for communicating with FDA about the safety evaluation.
    FDA has recently developed a form that interested persons may use 
to transmit their submission to the Office of Food Additive Safety in 
the Center for Food Safety and Applied Nutrition. New Form FDA 3666, a 
draft of which is available at http://www.fda.gov/downloads/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/FoodIngredientsandPackaging/RegulatorySubmissions/UCM199325.pdf, 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 FDA's 
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 (ESG), or may be submitted in paper 
format, or as electronic files on physical media with paper signature 
page. The information is used by FDA to evaluate the food safety of a 
specific new protein produced by a new plant variety.

II. NPC Information Submitted on Form FDA 3666

    The NPC submitted to FDA includes the following information on Form 
FDA 3666 and in attachments to the form:

[[Page 28603]]

A. Introductory Information About the Submission
     Whether the NPC submission is a new submission, or an 
amendment or supplement to a previously established NPC;
     Whether the submitter has determined that all files 
provided in an electronic transmission are free of computer viruses;
     The date of the submitter's most recent meeting (if any) 
with FDA before transmitting a new NPC submission; and
     The date of any correspondence, sent to the submitter by 
FDA, relevant to an amendment or supplement the submitter is 
transmitting.
B. Information About the Submitter
     The name of and contact information for the submitter, 
including the identity of the contact person and the company name (if 
applicable); and
     The name of and contact information for any agent or 
attorney who is authorized to act on behalf of the submitter.
C. General Administrative Information
     The title of the submission;
     The format of the submission (i.e., paper, electronic, or 
electronic with a paper signature page);
     The mode of transmission of any electronic submission 
(i.e., ESG or transmission on physical media such as CD-ROM or DVD);
     Whether the submitter is referring us to information 
already in our files;
     Whether the submitter has designated in its submission any 
information as trade secret or as confidential commercial or financial 
information; and
     Whether the submitter has attached a redacted copy of some 
or all of the submission.
D. Information About the New Protein
     The name of the new protein;
     Any requested registry designations for the new protein; 
and
     The purpose or intended technical effect of the new 
protein.
E. Information About Genetic Material
     Information about the introduced genetic material 
(including identity and source).
F. The Scientific Evaluation of the Food Safety of the New Protein
    The submitter indicates:
     Whether there is a history of safe use of the new protein 
in food or feed;
     Whether the submitter has included an assessment of the 
amino acid similarity between the new protein and known allergens and 
toxins;
     Whether the submitter has included information about the 
overall stability of the protein, and the resistance of the protein to 
enzymatic degradation using appropriate in vitro assays; and
     Whether the submitter has included any other information 
for FDA to consider in evaluating a NPC.

Form FDA 3666 also requires the signature of a responsible official (or 
agent or attorney) and a list of attachments.

III. Burden Estimates

    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\
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                                                                                             Number of                        Average
                 Category                          FDA form No.\2\           Number of     responses per   Total annual     burden per      Total hours
                                                                            respondents     respondent       responses       response
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First four data components................  Form FDA 3666...............              20               1              20               4              80
Two other data components.................  Form FDA 3666...............              20               1              20              16             320
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    Total.................................  ............................  ..............  ..............  ..............  ..............             400
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.
\2\ Form FDA 3666 may be submitted electronically via the ESG.

    The estimated number of annual responses and average burden per 
response are based on FDA's experience with early food safety 
evaluations submitted in the past 3 years. 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). Based on its experience 
over the past 3 years, FDA estimates that approximately 20 developers 
will choose to complete an early food safety evaluation for their new 
plant protein, for a total of 20 responses annually. 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 FDA about the food safety of a new plant 
protein, for example, when the same protein was expressed in a 
different crop.
    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. 
FDA estimates that completing these data components will take about 4 
hours per NPC. FDA estimates the reporting burden for the first four 
data components to be 80 hours (4 hours x 20 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. FDA estimates that completing these data components will take 
about 16 hours per NPC. FDA estimates the reporting burden for the two 
other data components to be 320 hours (16 hours x 20 responses). Thus, 
FDA estimates the total annual hour burden for this collection of 
information to be 400 hours.
    FDA expects that most if not all businesses filing NPCs in the next 
3 years will choose to take advantage of the option of electronic 
submission via the ESG. Thus, the burden estimates in Table 1 are based 
on the expectation of one hundred percent (100%)

[[Page 28604]]

participation in the electronic submission process. The opportunity to 
provide the information in electronic format could reduce the Agency's 
previous estimates for the time to prepare each submission. However, as 
a conservative approach for the purpose of this analysis, FDA is 
assuming that the availability of new Form FDA 3666 and the opportunity 
to submit the information in electronic format will have no effect on 
the average time to prepare a submission. While FDA does not charge for 
the use of the ESG, FDA requires respondents to obtain a public key 
infrastructure certificate in order to set up the account. This can be 
obtained in-house or outsourced by purchasing a public key certificate 
that is valid for 1 year to 3 years. The certificate typically costs 
from $20 to $30.

    Dated: May 9, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-11689 Filed 5-14-12; 8:45 am]
BILLING CODE 4160-01-P


