Food and Cosmetic Export Certificate Applications Process

Forms and Documents

Document Name	Status
Form Form FDA 3613e Food additives and food contact substances Form	Removed
Form Form FDA 3613e Dietary supplements, food for special dietary use, infant formula, & medical foods Form	Removed
Form Form FDA 3613e Food (including seafood) Form	Modified
Form FDA Form 3613d Cosmetics Form	Modified
0793 CFSAN Export Certs SSA 2018 Rev.pdf Supporting Statement A	2018-07-09

IC Document Collections

IC ID	Document Title	Status
216233	Food additives and food contact substances Form	Removed
216232	Dietary supplements, food for special dietary use, infant formula, & medical foods Form	Removed
216231	Food (including seafood) Form	Modified
216230	Cosmetics Form	Modified

ICR Details

OMB Control No: 0910-0793	ICR Reference No: 201804-0910-017
Status: Active	Previous ICR Reference No: 201504-0910-005
Agency/Subagency: HHS/FDA	Agency Tracking No: CFSAN
Title: Food and Cosmetic Export Certificate Applications Process
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Approved without change	Conclusion Date: 08/17/2018
	Date Received in OIRA: 05/17/2018
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	08/31/2021	36 Months From Approved	08/31/2018
Responses	5,215	0	3,294
Time Burden (Hours)	2,608	0	4,942
Cost Burden (Dollars)	52,150	0	32,940

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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 301, et seq. Name of Law: Food, Drug, and Cosmetic 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:
	83 FR 133	01/02/2018
30-day Notice:	Federal Register Citation:	Citation Date:
	83 FR 22984	05/17/2018
Did the Agency receive public comments on this ICR? Yes

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Number of Information Collection (IC) in this ICR: 2

IC Title	Form No.	Form Name
Food additives and food contact substances	Form FDA 3613e	Food Export Certificate Application
Dietary supplements, food for special dietary use, infant formula, & medical foods	Form FDA 3613e	Food Export Certificate Application
Cosmetics	FDA Form 3613d	OFFICE OF COSMETICS AND COLORS “CERTIFICATE” (EXPORTS) APPLICATION
Food (including seafood)	Form FDA 3613e, Form FDA 3613l, Form FDA 3613g	Food Export Certificate Application ,   Certificate Application Process ,   Certificate Application Process (animal derived products)

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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	5,215	3,294	0	0	1,921	0
Annual Time Burden (Hours)	2,608	4,942	0	0	-2,334	0
Annual Cost Burden (Dollars)	52,150	32,940	0	0	19,210	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 both adjustment and revision. This is discussed more fully in the agency's SS at question 15.

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Annual Cost to Federal Government: $1,550,000

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? 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: 05/17/2018

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