Imports and Electronic Import Entries

ICR 202107-0910-014

OMB: 0910-0046

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
Unchanged
Supporting Statement A
2021-07-14
ICR Details
0910-0046 202107-0910-014
Received in OIRA 202011-0910-007
HHS/FDA ORA
Imports and Electronic Import Entries
Revision of a currently approved collection   No
Regular 07/15/2021
  Requested Previously Approved
36 Months From Approved 06/30/2023
42,608,936 42,558,387
1,916,715 1,916,084
0 0

This information collection supports FDA import operations and regulations in 21 CFR part 1, subparts D & E. The regulations describe reporting elements that must be submitted for FDA-regulated products being imported into the United States, and related recordkeeping.

PL: Pub.L. 111 - 31 801 Name of Law: Tobacco Control Act
   US Code: 21 USC 381 Name of Law: FFDCA; Imports and Exports
  
None

0910-AH66 Proposed rulemaking 85 FR 46566 08/03/2020

No

  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 42,608,936 42,558,387 0 0 50,549 0
Annual Time Burden (Hours) 1,916,715 1,916,084 0 0 631 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
This rulemaking incorporates both one-time and recurring burden for specific data elements. This results in an additional 50,549 responses and 631 hours annually to the information collection.

$38,750,000
No
    Yes
    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.
07/15/2021


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