Recommendations for Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plan Varieties Intended for Food Use

ICR 200904-0910-008

OMB: 0910-0583

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2009-04-06
ICR Details
0910-0583 200904-0910-008
Historical Active 200602-0910-003
HHS/FDA
Recommendations for Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plan Varieties Intended for Food Use
Extension without change of a currently approved collection   No
Regular
Approved without change 07/18/2009
Retrieve Notice of Action (NOA) 04/17/2009
  Inventory as of this Action Requested Previously Approved
07/31/2012 36 Months From Approved 07/31/2009
20 0 20
400 0 400
0 0 0

Since 1992, when FDA issued its Statement of Policy: Foods Derived from New Plant Varieties (57 FR 22984, May 29, 1992), the Food and Drug Administration (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 titled, "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.

US Code: 21 USC 393 Name of Law: FFDCA
  
None

Not associated with rulemaking

  74 FR 906 01/09/2009
74 FR 17868 04/17/2009
No

  Total Approved Previously Approved Change Due to New Statute Change Due to Agency Discretion Change Due to Adjustment in Estimate Change Due to Potential Violation of the PRA
Annual Number of Responses 20 20 0 0 0 0
Annual Time Burden (Hours) 400 400 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$173,280
No
No
Uncollected
Uncollected
No
Uncollected
Jonnalynn Capezzuto 3018274659

  No

On behalf of this Federal agency, I certify that the collection of information encompassed by this request complies with 5 CFR 1320.9 and the related provisions of 5 CFR 1320.8(b)(3).
The following is a summary of the topics, regarding the proposed collection of information, that the certification covers:
 
 
 
 
 
 
 
    (i) Why the information is being collected;
    (ii) Use of information;
    (iii) Burden estimate;
    (iv) Nature of response (voluntary, required for a benefit, or mandatory);
    (v) Nature and extent of confidentiality; and
    (vi) Need to display currently valid OMB control number;
 
 
 
If you are unable to certify compliance with any of these provisions, identify the item by leaving the box unchecked and explain the reason in the Supporting Statement.
04/17/2009


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