FDA will resubmit this collection to account for changes to the final rule.
Inventory as of this Action
Requested
Previously Approved
06/30/2019
36 Months From Approved
06/30/2019
3,772,160
0
3,772,160
528,102
0
528,102
0
0
0
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).
FDA is revising this ICR for additional collection of information provisions in FDAâs 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 FDAâs proposed 21 CFR Part 1 Subpart D.
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.
Participating Government Agencies - FDA Supplemental Guide Release 2 4 1 Final.pdf
0046 ss 7-12-16.doc
Quality checks and data submission into ACE