Claim of Categorical Exclusions

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

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0541 can be found here:

Documents and Forms

Document Name Document Type
0541 Guidance for Industry for Preparing a Claim of Categorical Exclusion or Environmental Assessment.pdf Other-Agency Guidance

Information Collection (IC) Details

IC Title:	Claim of Categorical Exclusions	Agency IC Tracking Number:	CFSAN

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Required to Obtain or Retain Benefits

CFR Citation: 21 CFR 25.15(a)&(d) (under 25.32(a))

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Agency Guidance			0541 Guidance for Industry for Preparing a Claim of Categorical Exclusion or Environmental Assessment.pdf		Yes	No	Printable Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 3	Number of Respondents for Small Entity: 1

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 95 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	3	1	2
Annual IC Time Burden (Hours)	24	22	2
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

Title	Document	Date Uploaded
No associated records found

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.