Importer's Entry Notice

ICR 202003-0910-011

OMB: 0910-0046

Federal Form Document

Forms and Documents
Document
Name
Status
Form and Instruction
New
Supporting Statement A
2020-04-26
ICR Details
0910-0046 202003-0910-011
Historical Active 201706-0910-007
HHS/FDA ORA
Importer's Entry Notice
Revision of a currently approved collection   No
Regular
Approved without change 06/02/2020
Retrieve Notice of Action (NOA) 04/27/2020
  Inventory as of this Action Requested Previously Approved
06/30/2023 36 Months From Approved 06/30/2020
42,558,387 0 82,669,422
1,916,084 0 1,785,512
0 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.

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

Not associated with rulemaking

  85 FR 318 01/03/2020
85 FR 23048 04/24/2020
No

  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 42,558,387 82,669,422 0 0 -40,111,035 0
Annual Time Burden (Hours) 1,916,084 1,785,512 0 0 130,572 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
No
No
The information collection reflects program changes as well as adjustments. Cumulatively, these changes and revisions result in 40,111,035 fewer annual responses and 130,572 less burden hours to the information collection. This is discussed more fully in Questions 1 and 15 of our Supporting Statement.

$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.
04/27/2020


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