FDA Seeks Input on Import Entry Paperwork Burden
Published Date: 8/17/2026
Notice
Summary
The FDA wants your thoughts on how they collect info about imports and electronic import entries. If you’re involved in importing goods, this could affect you! They’re asking for comments by October 16, 2026, to help improve the process without adding extra costs or hassle.
Analyzed Economic Effects
7 provisions identified: 2 benefits, 4 costs, 1 mixed.
Mandatory Import Data Submissions
If you import or offer for import FDA-regulated products into the United States, you must submit required data elements for all imported products when filing entries (per 21 CFR part 1, subparts D and E). The collection supports submission through CBP's Automated Commercial Environment (ACE) or any CBP-authorized electronic data interchange system.
Large Aggregate Reporting Burden
FDA estimates the total annual reporting burden for this collection as 2,077,245 hours across all respondents and responses. The docket requests comments on burden, utility, and ways to reduce the burden under the Paperwork Reduction Act.
Formalized PLAIR Submission Process for Pre-Launch Imports
FDA's Pre-Launch Activities Importation Requests (PLAIR) guidance formalizes how applicants with pending new drug, abbreviated new drug, or CDER-regulated biologics licensing applications should request to import unapproved finished dosage forms for market launch preparation; PLAIR submissions should be on applicant letterhead and emailed to [email protected]. The collection estimates 320 PLAIR submissions at 16 hours each (5,120 hours total).
Weekly Entry Filing (WEF) Option for FTZs
If you remove FDA-regulated merchandise from a Foreign Trade Zone (FTZ) for U.S. consumption, you may use the Weekly Entry Filing (WEF) program to file a single weekly entry estimating removals over a 7-day period. FDA recommends requesting a preliminary assessment and submitting specific data elements to participate.
ITACS Electronic Status and Submission Tool
Importers and entry filers can use FDA's Import Trade Auxiliary Communication System (ITACS) to create an account, check entry status, submit entry documentation, report goods' availability location for lines targeted for examination, and check estimated laboratory analysis completion dates. The notice estimates 500 new account creations at 0.5 hours each (250 hours total).
Use of Specific FDA Import Forms (766 & 5054)
The information collection includes use of Form FDA 766 (Application for Authorization to Relabel or Recondition Non-compliant Articles) and electronic Form FDA 5054 (New Inquiry Form--Import Compliance Branch). The notice estimates 324 uses of Form FDA 766 at 0.25 hours each (81 hours) and 1,000 uses of Form FDA 5054 at 0.083 hours each (83 hours).
Public Comment Deadline for Import Collection
FDA is soliciting public comments on this information collection under the Paperwork Reduction Act, and comments must be submitted (electronically or in writing) by October 16, 2026. The notice asks for input on necessity, burden estimates, clarity, and ways to minimize burden.
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