[Federal Register Volume 77, Number 148 (Wednesday, August 1, 2012)]
[Pages 45622-45623]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-18765]



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.


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 August 
31, 2012.

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 oira_submission@omb.eop.gov. 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 Information 
Management, Food and Drug Administration, 1350 Piccard Dr., PI50-400T, 
Rockville, MD 20850, 301-796-5733, domini.bean@fda.hhs.gov.

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-

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:

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 

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

[[Page 45623]]

     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; 
     The purpose or intended technical effect of the new 

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 
     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. Public Comment

    In the Federal Register of May 15, 2012 (77 FR 28603), FDA 
published a 60-day notice requesting public comment on the proposed 
collection of information. No comments were received.

IV. Burden Estimate

    Description of Respondents: The respondents to this collection of 
information are developers of new plant varieties intended for food 
    FDA estimates the burden of this collection of information as 

                                                     Table 1--Estimated Annual Reporting Burden \1\
                                                                                           No. of
                Category                      FDA Form No.\ 2\            No. of       responses per     Total annual    Average burden    Total hours
                                                                       respondents       respondent       responses       per response
First four data components.............  Form FDA 3666.............              20                1               20                4               80
Two other data components..............  Form FDA 3666.............              20                1               20               16              320
    Total..............................  ..........................  ...............  ...............  ...............  ...............             400
\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 of this 
document are based on the expectation of 100 percent 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 (PKI) 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: July 27, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-18765 Filed 7-31-12; 8:45 am]