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

ICR 201509-0910-007

OMB: 0910-0583

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2015-10-07
ICR Details
0910-0583 201509-0910-007
Historical Active 201208-0910-002
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 11/06/2015
Retrieve Notice of Action (NOA) 10/08/2015
  Inventory as of this Action Requested Previously Approved
11/30/2018 36 Months From Approved 11/30/2015
6 0 20
120 0 400
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

  80 FR 35370 06/19/2015
80 FR 58487 09/29/2015
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 6 20 0 -14 0 0
Annual Time Burden (Hours) 120 400 0 -280 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
Yes
Miscellaneous Actions
The agency has decreased its burden estimate based on a decrease in the number of submissions. This change is discussed more fully at Q.15. of the supporting statement Part A.

$54,308
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.
10/08/2015


© 2024 OMB.report | Privacy Policy