Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition

Forms and Documents

Document Name	Status
0541 Supporting Statement Part A 2016.docx Supporting Statement A	2016-12-07

IC Document Collections

IC ID	Document Title	Status
6261	Claim of Categorical Exclusions Other-Agency Guidance	Modified
224584	Environmental Assessments Other-Agency Guidance	New
180960	Claim of Categorical Exclusions Other-Agency Guidance	Modified
180959	Claim of Categorical Exclusions Other-Agency Guidance	Modified

ICR Details

OMB Control No: 0910-0541	ICR Reference No: 201611-0910-009
Status: Historical Active	Previous ICR Reference No: 201312-0910-012
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition
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 without change	Conclusion Date: 01/12/2017
	Date Received in OIRA: 12/08/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	01/31/2020	36 Months From Approved	02/28/2017
Responses	108	0	45
Time Burden (Hours)	10,668	0	45
Cost Burden (Dollars)	0	0	0

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Abstract: This information collection request supports an agency guidance entitled, "Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition." The guidance identifies, interprets, and clarifies existing requirements imposed by statute and regulation, consistent with the Council on Environmental Quality regulations found at 40 CFR 1507.3. It consists of recommendations that do not themselves create requirements, but explain FDA's own procedures for ensuring compliance with the purposes and provisions of the National Environmental Policy Act of 1969 (NEPA). Respondents to this collection are businesses engaged in the manufacture or sale of food, food ingredients, and substances used in materials that come into contact with food, and are from the private sector.

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Authorizing Statute(s): US Code: 42 USC 4321-4347 Name of Law: National Environmental Policy Act
  

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:
	81 FR 58517	08/25/2016
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 83245	11/21/2016
Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 4

IC Title	Form No.	Form Name
Claim of Categorical Exclusions
Claim of Categorical Exclusions
Claim of Categorical Exclusions
Environmental Assessments

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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	108	45	0	0	63	0
Annual Time Burden (Hours)	10,668	45	0	0	10,623	0
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: The information collection reflects an overall increase. The number of respondents has changed from 45 to 108, reflecting an increase of 63. This results in a corresponding increase to burden hours from 45 to 10,668, an increase of 10,623. While we attribute the increase in submissions to an increase in respondents to the collection, we attribute a larger part of the increased burden hours to a reassessment of the time necessary to prepare submissions. Where previously we estimated one hour for the preparation of a submission, we have revised the estimate to eight hours.

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Annual Cost to Federal Government: $10,808

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: 12/08/2016

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