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

ICR 201208-0910-002

OMB: 0910-0583

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2012-08-01
ICR Details
0910-0583 201208-0910-002
Historical Active 200904-0910-008
HHS/FDA
Recommendations for Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plan Varieties Intended for Food Use
Reinstatement with change of a previously approved collection   No
Regular
Approved without change 10/15/2012
Retrieve Notice of Action (NOA) 08/02/2012
  Inventory as of this Action Requested Previously Approved
10/31/2015 36 Months From Approved
20 0 0
400 0 0
0 0 0

The Food and Drug Administration (FDA) encourages 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.

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

Not associated with rulemaking

  77 FR 28602 05/15/2012
77 FR 45622 08/01/2012
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 0 0 0 0 20
Annual Time Burden (Hours) 400 0 0 0 0 400
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$177,472
No
No
No
No
No
Uncollected
Domini Bean 301 796-5733 [email protected]

  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.
08/02/2012


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