7 CFR Part 340; Introduction of Organisms and Products Altered or Produced through Genetic Engineering

Forms and Documents

Document Name	Status
Form 2000 7 CFR Part 340; Introduction of Organisms and Products Altered or Produced through Genetic Engineering (Business) Form	Modified
0579-0085 2020 Summary of ICR Changes.xls Supplementary Document	2020-02-12
0579-0085 2020 SS (20200212).docx Supporting Statement A	2020-02-12
0579-0085 2020 APHIS 79 (20200130).XLS Supplementary Document	2020-01-30
0579-0085 2020 APHIS 71 (20200211).xls Supplementary Document	2020-02-11
Screen Shots - ePermits.pdf Supplementary Document	2014-11-25

IC Document Collections

IC ID	Document Title	Status
46188	7 CFR Part 340; Introduction of Organisms and Products Altered or Produced through Genetic Engineering (State)	Modified
2159	7 CFR Part 340; Introduction of Organisms and Products Altered or Produced through Genetic Engineering (Business) Form	Modified

ICR Details

OMB Control No: 0579-0085	ICR Reference No: 202001-0579-004
Status: Active	Previous ICR Reference No: 201411-0579-002
Agency/Subagency: USDA/APHIS	Agency Tracking No:
Title: 7 CFR Part 340; Introduction of Organisms and Products Altered or Produced through Genetic Engineering
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 05/14/2020
	Date Received in OIRA: 02/13/2020
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	05/31/2023	36 Months From Approved	05/31/2020
Responses	8,780	0	3,501
Time Burden (Hours)	12,983	0	3,315
Cost Burden (Dollars)	0	0	0

---

Abstract: The purpose of this collection is to ensure that certain genetically engineered organisms, when imported, moved interstate, or released into the environment will not present a risk of plant pest introduction.

---

Authorizing Statute(s): US Code: 7 USC 7701 Name of Law: Plant Protection Act
  

Citations for New Statutory Requirements: None

---

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

---

Federal Register Notices & Comments
60-day Notice:	Federal Register Citation:	Citation Date:
	84 FR 57385	10/25/2019
30-day Notice:	Federal Register Citation:	Citation Date:
	85 FR 7529	02/10/2020
Did the Agency receive public comments on this ICR? Yes

---

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

IC Title	Form No.	Form Name
7 CFR Part 340; Introduction of Organisms and Products Altered or Produced through Genetic Engineering (State)
7 CFR Part 340; Introduction of Organisms and Products Altered or Produced through Genetic Engineering (Business)	2000, APHIS 2050, APHIS 2051, APHIS 2052, APHIS 2053, APHIS 2054	Application for Permit or Courtesy Permit Under 7 CFR 340 ,   Interstate Movement Authorized ,   Label - Genetically Engineered Organisms ,   Label- CA Genetically Engineered Organisms ,   Label- NY - Genetically Engineered Organisms ,   Label - FL Genetically Engineered Organisms

---

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	8,780	3,501	0	1,455	3,824	0
Annual Time Burden (Hours)	12,983	3,315	0	2,687	6,981	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: This request for renewal adds 5,279 responses and 9,668 burden hours to the information collection. The discretionary changes are attributed to adding respondent types to existing activities, adding recordkeeping reporting to most activities, and adjusting response times for several activities. One new activity was added to the request, adding 38 responses and 228 hours of burden.

---

Annual Cost to Federal Government: $1,883,504

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.     No

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

---

Common Form ICR:  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:

(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: 02/13/2020

---