Food and Cosmetic Export Certificates

ICR 202107-0910-005

OMB: 0910-0793

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Modified
Form and Instruction
Modified
Supporting Statement A
2021-07-13
IC Document Collections
IC ID
Document
Title
Status
216231 Modified
216230 Modified
ICR Details
0910-0793 202107-0910-005
Received in OIRA 201804-0910-017
HHS/FDA CFSAN
Food and Cosmetic Export Certificates
Extension without change of a currently approved collection   No
Regular 07/14/2021
  Requested Previously Approved
36 Months From Approved 08/31/2021
4,551 5,215
2,276 2,608
45,510 52,150

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.

US Code: 21 USC 381 and 382 Name of Law: Food, Drug, and Cosmetic Act: Imports and Exports
  
None

Not associated with rulemaking

  86 FR 14452 03/16/2021
86 FR 36282 07/09/2021
Yes

2
IC Title Form No. Form Name
Cosmetics FDA 3613d Cosmetic Export Application
Food (including seafood) FDA 3613e, 3613k Food Export Certificate Application ,   CFSAN eCATS Account Access

  Total Request 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 4,551 5,215 0 0 -664 0
Annual Time Burden (Hours) 2,276 2,608 0 0 -332 0
Annual Cost Burden (Dollars) 45,510 52,150 0 0 -6,640 0
No
No
We have adjusted our estimate based on fewer submission received in the past 3 fiscal years. This results in a reduction of 664 responses and 332 hours annually, with a corresponding reduction in costs of $6,640.

$1,550,000
No
    No
    No
No
No
No
No
Domini Bean 301 796-5733 [email protected]

  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.
07/14/2021


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