New Plant Varieties Intended for Food Use

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form FDA 3666 EARLY FOOD SAFETY EVALUATION NPC NUMBER OF A NEW NON-PESTICIDAL PROTEIN PRODUCED BY A NEW PLANT VARIETY	Form	Modified	Available
Form FDA 3665 FINAL CONSULTATION FOR FOOD DERIVED FROM A NEW PLANT VARIETY	Form	Modified	Available
0583 New plant varieties SSA Ext 2024.docx	Supporting Statement A	Uploaded 2024-07-28	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
6306	Recommendations for Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plan Varieties Intended for Food Use	Form	Modified	EARLY FOOD SAFETY EVALUATION NPC NUMBER OF A NEW NON-PESTICIDAL PROTEIN PRODUCED BY A NEW PLANT VARIETY
6306	Recommendations for Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plan Varieties Intended for Food Use	Instruction	Modified
247648	Consultation procedures for foods derived from new plant varieties	Form	Modified	FINAL CONSULTATION FOR FOOD DERIVED FROM A NEW PLANT VARIETY
247648	Consultation procedures for foods derived from new plant varieties	Other-Agency User Guide COSM	Modified

ICR Details

OMB Control No: 0910-0583	ICR Reference No: 202407-0910-007
Status: Active	Previous ICR Reference No: 202103-0910-006
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: New Plant Varieties Intended for Food Use
Type of Information Collection: Extension without change of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 09/03/2024
Retrieve Notice of Action (NOA)	Date Received in OIRA: 07/29/2024
Terms of Clearance: Burden was moved from "Program Change Due to Agency Discretion" column to the "Change Due to Adjustment in Agency Estimate" column based on the descriptions of updates made to the ICs and overall burden estimates.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2027	36 Months From Approved	08/31/2024
Responses	78	0	58
Time Burden (Hours)	2,160	0	2,080
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection supports recommendations regarding consultation with FDA pertaining to new plant varieties intended for food use. Respondents to the collection of information are developers of new plant varieties intended for food use.

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Authorizing Statute(s): US Code: 21 USC 393 Name of Law: FFDCA
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
	Not associated with rulemaking

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Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 17854	03/12/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 60900	07/29/2024
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 2

table that charts list of burden

IC Title	Form No.	Form Name
Consultation procedures for foods derived from new plant varieties	FDA 3665	FINAL CONSULTATION FOR FOOD DERIVED FROM A NEW PLANT VARIETY
Recommendations for Early Food Safety Evaluation of New Non-Pesticidal Proteins Produced by New Plan Varieties Intended for Food Use	FDA 3666	EARLY FOOD SAFETY EVALUATION NPC NUMBER OF A NEW NON-PESTICIDAL PROTEIN PRODUCED BY A NEW PLANT VARIETY

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ICR Summary of Burden

table that charts list of burden

	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	78	58	0	0	20	0
Annual Time Burden (Hours)	2,160	2,080	0	0	80	0
Annual Cost Burden (Dollars)	0	0	0	0	0	0

Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Miscellaneous Actions

Burden decreases because of Program Change due to Agency Discretion: No

Burden Reduction Due to:

Short Statement: We have made minor adjustments to update our burden estimate to reflect recent annual response rates (increased initial consultations under the New Plant Variety consultation procedures by 20 responses, which resulted in an additional 80 burden hours) and to clarify the total number of responses under the Early Food Safety Evaluation procedures.

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Annual Cost to Federal Government: $838,237

Does this IC contain surveys, censuses, or employ statistical methods? No

Does this ICR request any personally identifiable information (see OMB Circular No. A-130 for an explanation of this term)? Please consult with your agency's privacy program when making this determination.     Yes

Does this ICR include a form that requires a Privacy Act Statement (see 5 U.S.C. §552a(e)(3))? Please consult with your agency's privacy program when making this determination.     No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? No

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 07/29/2024

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