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

ICR 201809-0910-001

OMB: 0910-0583

Federal Form Document

ICR Details
0910-0583 201809-0910-001
Active 201509-0910-007
HHS/FDA CFSAN
Recommendations for Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plant Varieties Intended for Food Use
Extension without change of a currently approved collection   No
Regular
Approved without change 10/30/2018
Retrieve Notice of Action (NOA) 09/28/2018
  Inventory as of this Action Requested Previously Approved
10/31/2021 36 Months From Approved 11/30/2018
6 0 6
120 0 120
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 us early in the development process to discuss possible scientific and regulatory issues that might arise. This collection supports submissions regarding the safety evaluation of new non-pesticidal proteins produced by new plant varieties intended for food. Respondents are developers of new plant varieties from the private sector.

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

Not associated with rulemaking

  83 FR 24315 05/25/2018
83 FR 49108 09/28/2018
Yes

  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 6 6 0 0 0 0
Annual Time Burden (Hours) 120 120 0 0 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$57,984
No
    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.
09/28/2018


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