Food and Cosmetic Export Certificates

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Form FDA 5077 FDA Export Certification Inquiry	Form and Instruction	New	Available
Form FDA 5077 FDA Export Certification Inquiry	Form and Instruction	New	Repair queued
Form FDA 3613k eCATS Module	Form and Instruction	Modified	Available
Form FDA 3613e Food Export Certificate Application	Form and Instruction	Modified	Available
Form FDA 3613e Food (including seafood)	Form and Instruction	Modified	Repair queued
Form FDA 3613d Cosmetic Export Application	Form and Instruction	Modified	Available
Form FDA 3613d Cosmetics	Form and Instruction	Modified	Repair queued
0793 Food and Cosmetic Export certs SSA 2024 REV.docx	Supporting Statement A	Uploaded 2024-08-08	Repair queued

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
269965	FDA Export Certification Inquiry	Form and Instruction	New	FDA Export Certification Inquiry
269965	FDA Export Certification Inquiry	Form and Instruction	New
216231	Food (including seafood)	Form and Instruction	Modified	eCATS Module
216231	Food (including seafood)	Form and Instruction	Modified	Food Export Certificate Application
216231	Food (including seafood)	Form and Instruction	Modified
216231	Food (including seafood)	Other-e-Form Screenshot w/Instruction	Modified
216230	Cosmetics	Form and Instruction	Modified	Cosmetic Export Application
216230	Cosmetics	Form and Instruction	Modified

ICR Details

OMB Control No: 0910-0793	ICR Reference No: 202404-0910-006
Status: Active	Previous ICR Reference No: 202107-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Food and Cosmetic Export Certificates
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: 09/10/2024
Retrieve Notice of Action (NOA)	Date Received in OIRA: 08/09/2024
Terms of Clearance: Note: This latest update should have been characterized as a "revision" not an "extension without change."

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	09/30/2027	36 Months From Approved	09/30/2024
Responses	14,098	0	4,551
Time Burden (Hours)	4,709	0	2,276
Cost Burden (Dollars)	47,380	0	45,510

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Abstract: This information collection request supports the submission of information in order to obtain export certificates from the Food and Drug Administration for food and cosmetic products regulated by the agency. Respondents to the collection are firms that wish to export US-manufactured food and cosmetic products to foreign countries that require export certificates.

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Authorizing Statute(s): US Code: 21 USC 381 and 382 Name of Law: Food, Drug, and Cosmetic Act: Imports and Exports
  

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:
	89 FR 42472	05/15/2024
30-day Notice:	Federal Register Citation:	Citation Date:
	89 FR 64925	08/08/2024
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 3

table that charts list of burden

IC Title	Form No.	Form Name
Cosmetics	FDA 3613d	Cosmetic Export Application
FDA Export Certification Inquiry	FDA 5077	FDA Export Certification Inquiry
Food (including seafood)	FDA 3613e, FDA 3613k	Food Export Certificate Application ,   eCATS Module

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ICR Summary of Burden

table that charts list 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	14,098	4,551	0	9,360	187	0
Annual Time Burden (Hours)	4,709	2,276	0	2,340	93	0
Annual Cost Burden (Dollars)	47,380	45,510	0	0	1,870	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: Since our last review of the information collection, we have adjusted our estimate of the number of respondents downward. At the same time, we have increased the number of responses per respondent and added new Form FDA 5077. Cumulatively these activities result in an estimated burden increase of 9,547 hours and 9,360 responses annually.

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Annual Cost to Federal Government: $1,850,000

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

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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: 08/09/2024

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