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.
Personalized for You
How does this regulation affect your finances?
Personalize government policy and PRIA will tell you what this federal register document means for your household, plus every other regulation we track. PRIA reads each provision against your financial profile to show you exactly what matters to your wallet.
Key Dates
Department and Agencies
Related Federal Register Documents
2026-16296, Substances Generally Recognized as Safe
The Food and Drug Administration (FDA or we) is proposing to require the submission of generally recognized as safe (GRAS) notices for the use of a human or animal food substance purported to be GRAS under the conditions of its intended use under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
2026-14073, Drug Establishment Registration and Drug Listing Requirements for Establishments Engaged in Distributed Manufacturing and Certain Foreign Establishments
The FDA wants to make it easier for drug makers who work in several locations to register as one company instead of many. They’re also updating rules for foreign drug companies to match new laws about handling health threats. If you’re in drug manufacturing, get ready to comment by September 11, 2026, and keep an eye on possible paperwork changes that could affect your business.
2026-13047, Establishment Registration and Product Listing for Tobacco Products
The FDA wants to make sure all tobacco product makers, both in the U.S. and abroad, register their businesses and list their products. This new rule closes a big gap by including foreign companies, helping the FDA keep better track of tobacco products for public health. Comments on this proposal are open until September 14, 2026, so affected businesses should get ready to update their info and possibly face new costs.
2026-16715, Agency Information Collection Activities; Proposed Collection; Comment Request; Investigational New Drug Application Requirements
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for review and clearance under the Paperwork Reduction Act of 1995.
2026-16714, Agency Information Collection Activities; Proposed Collection; Comment Request; Third Party Disclosure and Recordkeeping Requirements for Reportable Food
The Food and Drug Administration (FDA or the Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the information collection provisions of FDA's third-party disclosure and recordkeeping requirements for reportable food.
2026-16728, Gastroenterology-Urology Devices; Reclassification of Diagnostic Endoscopic Light Source Systems To Be Renamed Cystoscopic Systems Intended as an Aid for Detection of Bladder Cancer
The Food and Drug Administration (FDA) is proposing to reclassify diagnostic endoscopic light source systems (product code OAY), which are postamendments class III devices, from class III (premarket approval) into class II (special controls), subject to premarket notification. FDA is also proposing a new device classification regulation with the name "Cystoscopic system intended as an aid for detection of bladder cancer," along with special controls that FDA believes are necessary to provide a reasonable assurance of the safety and effectiveness of these devices.
Previous / Next Documents
Previous: 2026-16711, Type VII Veterinary Master File for Research and Development and Risk Reviews; Guidance for Industry; Availability
The Food and Drug Administration (FDA, Agency, or we) is announcing the availability of a final guidance for industry (GFI) #260 entitled "Type VII Veterinary Master File for Research and Development and Risk Reviews." This guidance describes FDA's current thinking regarding the use of Type VII Veterinary Master Files (Type VII VMFs). Type VII VMFs are appropriate for research and development of animal cells, tissues, and cell- and tissue-based products (ACTPs), gene therapies, and heritable intentional genomic alterations (IGAs) in animals.
Next: 2026-16713, Determination of Regulatory Review Period for Purposes of Patent Extension; BIZENGRI
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for BIZENGRI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.