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 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.
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