Importer's Entry Notice

Forms and Documents

Forms and supporting documents for this ICR

Document	Type	Status	Availability
Participating Government Agencies - FDA Supplemental Guide Release 2 4 1 Final.pdf	Supplementary Document	Uploaded 2016-07-12	Available
0046 ss 7-12-16.doc	Supporting Statement A	Uploaded 2016-07-12	Available

IC Document Collections

Information collection document groups

IC ID	Collection	Type	Status	Form
5700	Quality checks and data submission into ACE		Modified
222420	ONE-TIME BURDEN Adjusting to new requirements for quality checks and submission to ACE		New
222419	Preparing the required information (applies to unique lines only)		New
210811	Tobacco Products		Removed

ICR Details

OMB Control No: 0910-0046	ICR Reference No: 201607-0910-003
Status: Historical Inactive	Previous ICR Reference No: 201601-0910-008
Agency/Subagency: HHS/FDA	Agency Tracking No: ORA
Title: Importer's Entry Notice
Type of Information Collection: Revision of a currently approved collection	Common Form ICR:  No
Type of Review Request: Regular
OIRA Conclusion Action: Comment filed on proposed rule and continue	Conclusion Date: 11/22/2016
	Date Received in OIRA: 07/13/2016
Terms of Clearance: FDA will resubmit this collection to account for changes to the final rule.

table that charts list comparision

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	06/30/2019	36 Months From Approved	06/30/2019
Responses	3,772,160	0	3,772,160
Time Burden (Hours)	528,102	0	528,102
Cost Burden (Dollars)	0	0	0

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Abstract: This ICR collects certain FDA-specific information from importers in the Automated Commercial Environment (ACE) operated by Customs and Border Protection (CBP), at the time of filing entry, about the FDA-regulated products that are being imported or offered for import into the United States. FDA uses this information to electronically screen these products to determine the initial admissibility of the products and to keep violative FDA-regulated products from entering the United States. 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).

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Authorizing Statute(s): PL: Pub.L. 111 - 31 801 Name of Law: Tobacco Control Act
   US Code: 21 USC 801 Name of Law: FFDCA
   US Code: 21 USC 536 Name of Law: FFDCA
   US Code: 21 USC 701 Name of Law: FFDCA
  

Citations for New Statutory Requirements: None

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Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AH41	Proposed rulemaking	81 FR 43155	07/01/2016

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Federal Register Notices & Comments

Did the Agency receive public comments on this ICR? No

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Number of Information Collection (IC) in this ICR: 3

table that charts list of burden

IC Title	Form No.	Form Name
Quality checks and data submission into ACE
Preparing the required information (applies to unique lines only)
Tobacco Products
ONE-TIME BURDEN Adjusting to new requirements for quality checks and submission to ACE

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Burden increases because of Program Change due to Agency Discretion: Yes

Burden Increase Due to: Changing Regulations

Burden decreases because of Program Change due to Agency Discretion: Yes

Burden Reduction Due to: Changing Regulations

Short Statement: FDA is revising this ICR for additional collection of information provisions in FDA’s proposed 21 CFR Part 1 Subpart D to account for several adjustments and program changes: We are adjusting the estimated burden currently approved under OMB 0910-0046 (not yet accounting for the proposed rule) from 522,421 hours to 1,039,957 hours, which is an adjustment increase of 517,536 hours, to account for an increase in FDA-regulated import lines and to correct for a previous accidental. We are also requesting a program change increase of 1,246,699 hours in the first year and 1,117,238 hours recurring after the first year to account for additional collection of information provisions in FDA’s proposed 21 CFR Part 1 Subpart D.

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Annual Cost to Federal Government: $16,403,650

Does this IC contain surveys, censuses, or employ statistical methods? No

Is the Supporting Statement intended to be a Privacy Impact Assessment required by the E-Government Act of 2002? No

Is this ICR related to the Affordable Care Act [Pub. L. 111-148 & 111-152]? No

Is this ICR related to the Dodd-Frank Wall Street Reform and Consumer Protection Act, [Pub. L. 111-203]? No

Is this ICR related to the American Recovery and Reinvestment Act of 2009 (ARRA)? No

Is this ICR related to the Pandemic Response? Uncollected

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Common Form ICR:  No

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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:

(a) It is necessary for the proper performance of agency functions;

(b) It avoids unnecessary duplication;

(c) It reduces burden on small entities;

(d) It uses plain, coherent, and unambiguous language that is understandable to respondents;

(e) Its implementation will be consistent and compatible with current reporting and recordkeeping practices;

(f) It indicates the retention periods for recordkeeping requirements;

(g) It informs respondents of the information called for under 5 CFR 1320.8 (b)(3) about:

(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;

(h) It was developed by an office that has planned and allocated resources for the efficient and effective management and use of the information to be collected.

(i) It uses effective and efficient statistical survey methodology (if applicable); and

(j) It makes appropriate use of information technology.

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.

Certification Date: 07/13/2016

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