[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\
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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 data components 20 1 20 4 80
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Two other data components 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.
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