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

ICR 200706-0910-004

OMB: 0910-0541

Federal Form Document

Forms and Documents
Document
Name
Status
Supplementary Document
2007-08-09
Supplementary Document
2007-06-13
Supplementary Document
2007-06-13
Supplementary Document
2007-06-13
Supporting Statement A
2007-06-13
ICR Details
0910-0541 200706-0910-004
Historical Active 200403-0910-002
HHS/FDA
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 09/26/2007
Retrieve Notice of Action (NOA) 06/28/2007
  Inventory as of this Action Requested Previously Approved
09/30/2010 36 Months From Approved 09/30/2007
171 0 147
171 0 147
0 0 0

As an integral part of its decision making process, the Food and Drug Administration (FDA) is obligated under the National Environmental Policy Act of 1969 (NEPA) to consider the environmental impact of its actions, including allowing notifications for food contact substances to become effective and approving food additive petitions, color additive petitions, GRAS affirmation petitions, requests for exemption from regulation as a food additive, and actions on certain food labeling citizen petitions, nutrient content claims petitions, and health claims petitions. In 1997, FDA amended its regulations in part 25 (21 CFR part 25) to provide for categorical exclusions for additional classes of actions that do not individually or cumulatively have a significant effect on the human environment (62 FR 40570, July 29, 1997). As a result of that rulemaking, FDA no longer routinely requires submission of information about the manufacturing and production of FDA-regulated articles. FDA also has eliminated the previously required Environmental Assessment (EA) and abbreviated EA formats from the amended regulations. Instead, FDA has provided guidance that contains sample formats to help industry submit a claim of categorical exclusion or an EA to the Center for Food Safety and Applied Nutrition (CFSAN). The guidance document entitled, Preparing a Claim of Categorical Exclusion or an Environmental Assessment for Submission to the Center for Food Safety and Applied Nutrition identifies, interprets, and clarifies existing requirements imposed by statute and regulation, consistent with the Council on Environmental Quality regulations (40 CFR 1507.3). It consists of recommendations that do not themselves create requirements; rather, they are explanatory guidance for FDAs own procedures in order to ensure full compliance with the purposes and provisions of NEPA.

US Code: 21 USC 393 Name of Law: FFDCA
  
None

Not associated with rulemaking

  72 FR 14581 03/28/2007
72 FR 11111 06/21/2007
No

  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 171 147 0 0 24 0
Annual Time Burden (Hours) 171 147 0 0 24 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No

$15,390
No
No
Uncollected
Uncollected
Uncollected
Uncollected
Saleda Perryman

  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.
06/28/2007


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