Guidance on Consultation Procedures: Foods Derived From New Plant Varieties

Forms and Documents

Document Name	Status
Form 3665 Reporting: Final Consultation Form and Instruction	New
FDA-3665 Form_B _v3 0_RD-03-01-11.pdf Supplementary Document	2011-07-06
Guidance on Consultation Procedures Foods Derived from New Plant Varieties.pdf Supplementary Document	2011-07-06
1992 Statement of Policy Foods Derived from New Plant Varieties.doc Supplementary Document	2011-07-06
SS - Biotech Consultation Procedures 07-01-2011.doc Supporting Statement A	2011-07-07

IC Document Collections

IC ID	Document Title	Status
198449	Reporting: Final Consultation Form and Instruction	New
198448	Reporting: Initial Consultation Other-Guidance	New

ICR Details

OMB Control No: 0910-0704	ICR Reference No: 201107-0910-003
Status: Historical Active	Previous ICR Reference No:
Agency/Subagency: HHS/FDA	Agency Tracking No:
Title: Guidance on Consultation Procedures: Foods Derived From New Plant Varieties
Type of Information Collection: Existing collection in use without an OMB Control Number	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved with change	Conclusion Date: 02/27/2012
	Date Received in OIRA: 07/07/2011
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	02/28/2015	36 Months From Approved
Responses	52	0	0
Time Burden (Hours)	1,960	0	0
Cost Burden (Dollars)	0	0	0

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Abstract: FDA instituted a voluntary consultation process with industry to promote communication and to ensure that any potential food safety issues regarding a new plant variety are resolved during development, and will help to ensure that all market entry decisions by the industry are made consistently and in full compliance with the standards of the FD&C Act.

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Authorizing Statute(s): US Code: 21 USC 321(s) Name of Law: null
   US Code: 21 USC 348 Name of Law: FFDCA
   US Code: 21 USC 342(a)(1) Name of Law: null
   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:
	75 FR 7274	02/18/2010
30-day Notice:	Federal Register Citation:	Citation Date:
	76 FR 9020	02/16/2011
Did the Agency receive public comments on this ICR? Yes

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

IC Title	Form No.	Form Name
Reporting: Initial Consultation
Reporting: Final Consultation	3665	Final Consultation For Food Derived From A New Plant Variety

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ICR Summary 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	52	0	0	0	0	52
Annual Time Burden (Hours)	1,960	0	0	0	0	1,960
Annual Cost Burden (Dollars)	0	0	0	0	0	0

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

Burden Increase Due to:

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

Burden Reduction Due to:

Short Statement:

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Annual Cost to Federal Government: $660,000

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

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? 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? Uncollected

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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: 07/07/2011

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