Importer's Entry Notice

ICR 201611-0910-008

OMB: 0910-0046

Federal Form Document

Forms and Documents
Document
Name
Status
No forms / supporting documents in this ICR. Check IC Document Collections.
ICR Details
0910-0046 201611-0910-008
Historical Inactive 201601-0910-008
HHS/FDA ORA
Importer's Entry Notice
Revision of a currently approved collection   No
Regular
Preapproved 12/23/2016
Retrieve Notice of Action (NOA) 11/23/2016
  Inventory as of this Action Requested Previously Approved
12/31/2019 36 Months From Approved 06/30/2019
82,669,422 0 3,772,160
1,785,512 0 528,102
0 0 0

Section 801 of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) charges the Secretary of Health and Human Services (HHS), through the FDA, with the responsibility of assuring foreign origin FDA regulated foods, drugs, cosmetics, medical devices, radiological health, and tobacco products offered for import into the United States meet the same requirements of the Act as do domestic products, and for preventing products from entering the country if they are not in compliance. The discharge of this responsibility involves close coordination and cooperation between FDA headquarters and field inspectional personnel and the U.S. Customs Service (USCS), as the USCS is responsible for enforcing the revenue laws covering the very same products. This collection of information is being used by FDA to review and prevent imported products from entering the United States if the products do not meet the same requirements of the FD&C Act as domestic products. Most of the information FDA requires to carry out its regulatory responsibilities under section 801 is already provided electronically by filers to USCS. Because USCS relays this data to FDA using an electronic interface, the majority of data submitted by the entry filer need be completed only once. In addition to the information collected by USCS, FDA requires four additional pieces of information that were not available from USCS's system in order to make an admissibility decision for each entry. These data elements include the FDA Product Code, FDA country of production, manufacturer/shipper, and ultimate consignee. OMB has previously approved the automated collection of these four data elements for tobacco products that filers could provide to FDA along with other entry-related information. Providing this information to FDA results in importers receiving an FDA admissibility decision more expeditiously, e.g., the quantity, value, and Affirmation(s) of Compliance with Qualifier(s).

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

0910-AH41 Final or interim final rulemaking

81 FR 43155 07/01/2016
Yes

  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 82,669,422 3,772,160 0 78,897,262 0 0
Annual Time Burden (Hours) 1,785,512 528,102 0 1,257,410 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Changing Regulations
No
This contains new provisions in a final rule revising an existing ICR.

$38,750,000
No
No
No
No
No
Uncollected
Jonna Capezzuto 301 796-3794 [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.
11/23/2016


© 2024 OMB.report | Privacy Policy