[Federal Register Volume 74, Number 6 (Friday, January 9, 2009)]
[Notices]
[Pages 906-908]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E9-213]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

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


Agency Information Collection Activities; Proposed Collection; 
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 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

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the information collection provisions of 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 written or electronic comments on the collection of 
information by March 10, 2009.

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

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.

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, 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.
    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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                      No. of         Annual Frequency       Total Annual        Hours per
                   Respondents         per Response          Responses           Response         Total Hours
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First four                     20                     1                 20                  4                 80
 data
 components
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Two other data                 20                     1                 20                 16                320
 components
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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.

    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

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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.
    Please note that on January 15, 2008, the FDA Division of Dockets 
Management Web site transitioned to the Federal Dockets Management 
System (FDMS). FDMS is a Government-wide, electronic docket management 
system. Electronic comments or submissions will be accepted by FDA only 
through FDMS at http://www.regulations.gov.

    Dated: December 30, 2008.
Jeffrey Shuren,
Associate Commissioner for Policy and Planning.
[FR Doc. E9-213 Filed 1-8-09; 8:45 am]
BILLING CODE 4160-01-S