Importer's Entry Notice

ICR 201601-0910-008

OMB: 0910-0046

Federal Form Document

Forms and Documents
Document
Name
Status
Supporting Statement A
2016-05-19
IC Document Collections
IC ID
Document
Title
Status
5700
Unchanged
210811
Modified
ICR Details
0910-0046 201601-0910-008
Historical Active 201406-0910-004
HHS/FDA ORA
Importer's Entry Notice
Revision of a currently approved collection   No
Regular
Approved without change 06/27/2016
Retrieve Notice of Action (NOA) 05/12/2016
  Inventory as of this Action Requested Previously Approved
06/30/2019 36 Months From Approved 06/30/2017
3,772,160 0 3,731,574
528,102 0 522,421
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).

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

0910-AG38 Final or interim final rulemaking 81 FR 28973 05/10/2016

  79 FR 23141 04/25/2014
81 FR 28973 05/10/2016
Yes

2
IC Title Form No. Form Name
Non-Tobacco Products
Tobacco Products

  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 3,772,160 3,731,574 0 40,586 0 0
Annual Time Burden (Hours) 528,102 522,421 0 5,681 0 0
Annual Cost Burden (Dollars) 0 0 0 0 0 0
Yes
Changing Regulations
No
The Food and Drug Administration (FDA) issued a final rule to deem products meeting the statutory definition of “tobacco product” to be subject to the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FD&C Act provides FDA authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and any other tobacco products that the Agency by regulation deems to be subject to the law. This final rule extends the Agency’s “tobacco product” authorities to all other categories of products that meet the statutory definition of “tobacco product” in the FD&C Act, except accessories of such newly deemed tobacco products.

$10,281,925
No
No
No
No
No
Uncollected
Jonna Capezzuto 301 796-3794 jonnalynn.capezzuto@fda.hhs.gov

  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.
05/12/2016


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