Document ID: FDA-2008-N-0657-0002
Agency: fda
Document Type: Notice
Title: Agency Information Collection Activities; Proposals, Submissions, and Approvals
Posted Date: 2009-04-17T04:00Z

[Federal Register: April 17, 2009 (Volume 74, Number 73)]
[Notices]               
[Page 17868-17869]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr17ap09-75]                         

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. FDA-2008-N-0657]

 
Agency Information Collection Activities; Submission for Office 
of Management and Budget Review; Comment Request; Recommendations for 
the 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

[[Page 17869]]

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 May 18, 
2009.

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: 202-395-6974, or e-mailed 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: Jonna Capezzuto, Office of Information 
Management (HFA-710), Food and Drug Administration, 5600 Fishers Lane, 
Rockville, MD 20857, 301-796-3794.

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.

Recommendations for the 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 (57 FR 22984), 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. 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.
    The respondents to this collection of information are developers of 
new plant varieties intended for food use.
    In the Federal Register of January 9, 2009 (74 FR 906), FDA 
published a 60-day notice requesting public comment on the information 
collection provisions. No comments were received.
    FDA estimates the burden of this collection of information as 
follows:

                                                     Table 1.--Estimated Annual Reporting Burden\1\
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                              No. of         Annual Frequency       Total Annual        Hours Per
                                                           Respondents         per Response          Responses           Response         Total Hours
--------------------------------------------------------------------------------------------------------------------------------------------------------
First four data components                                             20                     1                 20                  4                 80
--------------------------------------------------------------------------------------------------------------------------------------------------------
Two other data components                                              20                     1                 20                 16                320
--------------------------------------------------------------------------------------------------------------------------------------------------------
Total                                                                                                                                                400
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\1\ There are no capital costs or operating and maintenance costs associated with this collection of information.

    FDA estimates the annual total hour burden for this collection of 
information to be 400 hours. This estimate is based on early food 
safety evaluations submitted in the past 3 years. FDA's estimate of the 
time that it would take a respondent to prepare the data components of 
the early food safety evaluation submission is based on the agency's 
experience with similar submissions.
    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. 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 evaluation. In table 1 of this document, row 1 shows that for 
20 evaluations, the total burden for these 4 data components is 80 
hours.
    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 to submit to FDA. 
We estimate that these two data components will take 16 hours to 
complete (8 hours for each component). In table 1 of this document, row 
2 shows that for 20 evaluations, the total burden for these two data 
components is 320 hours.

    Dated: April 10, 2009.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-8773 Filed 4-16-09; 8:45 am]

BILLING CODE 4160-01-S