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

ICR 201611-0910-009

OMB: 0910-0541

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2016-12-07
ICR Details
0910-0541 201611-0910-009
Historical Active 201312-0910-012
HHS/FDA CFSAN
Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition
Extension without change of a currently approved collection   No
Regular
Approved without change 01/12/2017
Retrieve Notice of Action (NOA) 12/08/2016
  Inventory as of this Action Requested Previously Approved
01/31/2020 36 Months From Approved 02/28/2017
108 0 45
10,668 0 45
0 0 0

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.

US Code: 42 USC 4321-4347 Name of Law: National Environmental Policy Act
  
None

Not associated with rulemaking

  81 FR 58517 08/25/2016
81 FR 83245 11/21/2016
No

4
IC Title Form No. Form Name
Claim of Categorical Exclusions
Claim of Categorical Exclusions
Claim of Categorical Exclusions
Environmental Assessments

  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
No
No
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.

$10,808
No
No
No
No
No
Uncollected
Ila Mizrachi 301 796-7726 ila.mizrachi@fda.hhs.gov

  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.
12/08/2016


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