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OMB Control No: 0910-0046	ICR Reference No: 201611-0910-008
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: Preapproved	Conclusion Date: 12/23/2016
	Date Received in OIRA: 11/23/2016
Terms of Clearance:

	Inventory as of this Action	Requested	Previously Approved
Expiration Date	12/31/2019	36 Months From Approved	06/30/2019
Responses	82,669,422	0	3,772,160
Time Burden (Hours)	1,785,512	0	528,102
Cost Burden (Dollars)	0	0	0

Abstract: 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).

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

Citations for New Statutory Requirements: None

Associated Rulemaking Information
RIN:	Stage of Rulemaking:	Federal Register Citation:	Date:
0910-AH41	Final or interim final rulemaking

Federal Register Notices & Comments
30-day Notice:	Federal Register Citation:	Citation Date:
	81 FR 43155	07/01/2016
Did the Agency receive public comments on this ICR? Yes

ICR Summary of Burden

	Total Request	Previously Approved	Change Due to Agency Discretion
Annual Number of Responses	82,669,422	3,772,160	78,897,262
Annual Time Burden (Hours)	1,785,512	528,102	1,257,410
Annual Cost Burden (Dollars)	0	0	0

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: No

Burden Reduction Due to:

Short Statement: This contains new provisions in a final rule revising an existing ICR.

Annual Cost to Federal Government: $38,750,000

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

Agency Contact: Jonna Capezzuto 301 796-3794 jonnalynn.capezzuto@fda.hhs.gov

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