FDA Asks Exporters to Weigh In on Certificate Paperwork
Published Date: 10/23/2026
Notice
Summary
The FDA wants your thoughts on how they collect info for export certificates on FDA-regulated products. If you’re involved in exporting these products, this is your chance to speak up before December 22, 2026. No big fee changes yet, just a smooth process check to keep exports running strong!
Analyzed Economic Effects
9 provisions identified: 4 benefits, 5 costs, 0 mixed.
Estimated Annual Reporting Burden: 50,944 Hours
FDA estimates the annual reporting burden for these export certificate forms totals 50,944 hours across centers, reflecting an overall increase of 3,052 responses and an increase of 17,021 hours compared to the prior estimate.
Per-Certificate Fee Cap of $175
FDA may charge firms a fee not to exceed $175 to offset Agency resource expenditures for processing export certificate requests. The statutory provision allowing a fee of up to $175 is stated in the notice.
Requirement for Electronic Submission (CBER & CVM)
The Centers for Biologics Evaluation and Research (CBER) and the Center for Veterinary Medicine (CVM) are transitioning to a requirement for electronic submission of forms related to biological products, medical devices, and food/drugs/devices for animals and are revising Forms 3613, 3613a, and 3613b to remove paper submission instructions for those product areas.
New National Drug Code Field for Animal Drugs
CVM intends to add a field on the export certificate form for insertion of the National Drug Code (NDC), the product listing number legally required for animal drugs.
CBER Revision of Exporter Certification Statement
CBER is revising the exporter's certification statement on FDA Form 3613 for human cells, tissues, and cellular and tissue-based products (HCT/Ps) to align with the Certificate to Foreign Government and to provide clearer examples of compliance with 21 CFR Part 1271.
Two New CVM Forms for Free Sale and GMP
CVM is adding two new forms: FDA Form 3613h (Supplementary Information; Certificate of Free Sale) and FDA Form 3613i (Supplementary Information; Current Good Manufacturing Practice Certificate). These forms were created to improve clarity because previously one form was used for multiple certificate types.
CARES Act Supplemental Information Included
The collection scope includes provisions introduced under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) that may require supplemental information for exported product certificates; those data elements have been incorporated into current form versions.
20-Day Requirement for Issuing Export Certifications
Section 801(e)(4) of the FD&C Act requires FDA to issue written export certifications within 20 days of any request. The notice reiterates that statutory timing requirement.
Export Certificate Issuance Does Not Prevent Regulatory Action
The notice states that FDA's issuance of an export certificate does not preclude the Agency from taking appropriate regulatory action against a product covered by the certificate.
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
2026-20848, Use of Salt Substitutes To Reduce the Sodium Content in Standardized Foods
The FDA is changing food rules to allow salt substitutes in many standardized foods, helping companies make lower-sodium options. This move aims to cut heart disease risks by reducing sodium without changing how foods basically taste or look. The new rule kicks in December 14, 2026, and food makers have until November 12, 2026, to raise any concerns, with no big costs expected.
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.
2025-04978, Nonprescription Drug Product With an Additional Condition for Nonprescription Use
The FDA is delaying a new rule about nonprescription drugs that have extra conditions for use. Originally set to start on March 21, 2025, the rule’s start date is now pushed back to May 27, 2025, to allow more time for review. This affects drug makers and consumers by giving everyone extra time to prepare for the new requirements without any immediate cost changes.
2025-01840, Nonprescription Drug Product With an Additional Condition for Nonprescription Use
The FDA’s new rule about nonprescription drugs needing extra conditions before use was set to start on January 27, 2025, but it’s now delayed until March 21, 2025. This delay follows a presidential order to pause and review new rules before they take effect. Drug makers, sellers, and consumers should note the new start date and get ready for the updated rules soon.
Previous / Next Documents
Previous: 2026-21713, Agency Information Collection Activities; Proposed Collection; Comment Request; Product Jurisdiction and Combination Products
The FDA wants your thoughts on how they collect info about which products they regulate, especially combo products like drug-device mixes. This helps them keep rules clear and up to date. If you’re a company or person involved with these products, speak up by December 22, 2026—no cost changes yet, just a chance to shape the process!
Next: 2026-21715, Agency Information Collection Activities; Submission for OMB Review; Comment Request; U.S. Information Returns and Related Forms, Schedules, Attachments, and Published Guidance
The Treasury Department is asking for public feedback on its plan to update and combine tax-related forms and paperwork under one approval number. This affects businesses and individuals who file U.S. information returns, aiming to make the process smoother without adding extra costs. Comments are due by November 23, 2026, so don’t miss your chance to weigh in!