When Is FDA Form 3794 Required? (w/Examples) + FAQs

FDA Form 3794 is required whenever a company submits an Abbreviated New Drug Application (ANDA) for a generic drug, pays fees for a Type II Drug Master File (DMF), or owes annual facility or program fees under the Generic Drug User Fee Amendments (GDUFA). This form serves as the official cover sheet that calculates and documents user fee payments to the FDA.

Under Section 744B of the Federal Food, Drug, and Cosmetic Act, the FDA collects mandatory fees from generic drug manufacturers to fund its review operations. Missing or incorrectly filing Form 3794 triggers severe consequences: the FDA will refuse to receive your application, place your company on a public arrears list, and deem all drugs manufactured at non-compliant facilities as misbranded—making interstate commerce and importation illegal.

For Fiscal Year 2026, generic drug applicants face a standard ANDA fee of $358,247—a 10% increase from the previous year. The stakes are high: approximately 90% of prescriptions filled in the United States are generic drugs, and any fee-related delay can cost companies millions in lost revenue and market access.

In this article, you will learn:

📋 Exactly when Form 3794 is required for your specific submission type (ANDA, DMF, facility, or program fees)

💰 Current FY 2026 fee amounts and how domestic versus foreign locations affect your costs

⚠️ The four catastrophic consequences of missing deadlines or filing incorrectly

✅ Step-by-step guidance for completing each section of Form 3794 without errors

🔍 Real-world examples showing what happens when companies get it right—and wrong

What Is FDA Form 3794?

FDA Form 3794 is the Generic Drug User Fee Cover Sheet. It functions as the official payment and documentation form for all fees collected under GDUFA. The FDA uses this form to verify that applicants have satisfied their user fee obligations before beginning any substantive review of submissions.

The form exists because Congress passed the Generic Drug User Fee Amendments in 2012 to fund FDA’s generic drug review program. Before GDUFA, generic drug applications sat in backlogs that stretched for years. User fees now generate approximately $638 million annually for FDA operations, enabling faster reviews and inspections.

You must complete Form 3794 online at the FDA User Fee System. The system automatically calculates fees based on your inputs. Paper submissions are not accepted—all generic drug submissions must be in electronic Common Technical Document (eCTD) format.

The Four Fee Types Requiring Form 3794

Form 3794 covers four distinct fee categories. Each category has different triggers, deadlines, and amounts. Understanding which fees apply to your situation prevents costly errors.

1. ANDA Application Fees

The ANDA fee applies to original submissions and certain amendments. This is a one-time fee paid when you submit an application to market a generic drug product.

The fee is due at the time of submission. If the FDA receives your ANDA without full payment, the application is deemed incomplete and will not be accepted for filing.

2. Drug Master File (DMF) Fees

DMF fees apply to Type II Active Pharmaceutical Ingredient (API) Drug Master Files. The fee triggers when the DMF is first referenced in a generic drug submission on or after October 1, 2012.

The FY 2026 DMF fee is $102,584. DMF holders should pay this fee at least three months before an ANDA applicant plans to reference the DMF. This timing allows the FDA to complete its Completeness Assessment before the ANDA filing review window closes.

If the DMF fee remains unpaid within 20 calendar days of notification, the FDA will refuse to receive any ANDA referencing that DMF. The filing date resets to the date all outstanding fees are paid.

3. Facility Fees

Annual facility fees apply to any manufacturing site referenced in at least one approved generic drug submission. These fees fund FDA inspections and surveillance activities.

The $15,000 differential for foreign facilities covers additional inspection costs incurred when FDA conducts overseas inspections. Facilities engaged in both API and FDF manufacturing pay only the FDF fee—not both.

4. Program Fees (ANDA Holder Fees)

Program fees are annual fees assessed on companies that hold approved ANDAs. The fee amount depends on how many ANDAs a company and its affiliates collectively own.

The program fee tier is determined by ANDA ownership on the due date. If you want to reduce your tier, you must submit written withdrawal requests by April 1 of the previous fiscal year.

When Form 3794 Is NOT Required: Exemptions

Certain submissions are exempt from GDUFA fees. Understanding these exemptions prevents unnecessary payments.

Positron Emission Tomography (PET) Drugs

PET drug manufacturers receive a full exemption from all GDUFA fees. This includes FDG, Ammonia N13, and Sodium Fluoride F18. Applicants do not need to request waivers—the exemption is automatic when you indicate your product is a PET drug on Form 3794.

State and Federal Government Entities

Applications submitted by state or federal government entities for drugs not distributed commercially are exempt. The key phrase is “not distributed commercially”—any financial reimbursement, including cost recovery, makes the distribution commercial and eliminates the exemption.

Step-by-Step: Completing Form 3794

Form 3794 must be completed online. A signed copy goes in your ANDA submission (with Form 356h) or with the cover letter for DMF submissions. Each field serves a specific verification purpose.

General Information (Fields 1-4)

Field 1: Applicant, Holder, or Owner

Enter the legal entity that owns or controls the submission. This is the name and address of record—not the physical facility location unless they match.

Field 2: Representative or U.S. Agent

Foreign companies must provide a U.S. agent who can respond to FDA questions. This person needs a U.S. address, telephone number, and email.

Field 3: Fiscal Year

The U.S. government fiscal year runs October 1 through September 30. FY 2026 began October 1, 2025. Select the fiscal year to which your payment applies.

Field 4: Generic Drug User Fee Type

Check the appropriate box for your fee type: ANDA, Generic Drug Applicant Program, Type II API Drug Master File, or Facility. Your selection determines which subsequent fields you must complete.

ANDA Information (Fields 5-16)

Field 5: Application Number

Provide the six-digit ANDA number. If your number has fewer digits, add leading zeros (for example, ANDA 012345).

Field 7: Amending ANDA

Indicate whether you are amending an ANDA that has been submitted but not yet received a final official action. Amendments submitted after a Refuse-to-Receive determination require a new fee.

Field 8: API Manufacturing Information Included

Some ANDAs contain API manufacturing information without referencing a Type II DMF. If your application includes such information, you must pay the Section 744B(a)(3)(F) fee for API/facility combinations.

Fields 15-16: Exemptions

Field 15 covers PET drug exemptions. Field 16 covers non-commercial government entity exemptions. Mark these fields accurately—false claims trigger enforcement action.

DMF Information (Fields 19-22)

Field 19: Type II API DMF Number

Enter the DMF number exactly as assigned. This number should match what appears on the FDA DMF database.

Field 20: Name of Drug Substance

Provide the exact name of the API covered by the DMF. Inconsistencies between the DMF and your ANDA create review delays.

Facility Information (Fields 23-25)

Field 23: U.S. Facility

Indicate whether your facility is in the United States, its territories, or possessions. This determines whether you pay domestic or foreign fee rates.

Field 24: Facility Identifiers

Provide the facility’s FDA Establishment Identifier (FEI) and DUNS number. The FEI is issued by FDA’s Office of Regulatory Affairs. Use the “establishment DUNS”—not the registrant DUNS.

Field 25: Type of Facility

A facility is defined as one management at one geographic location engaged in manufacturing APIs or FDFs. Entities that only repackage, relabel, or test are not facilities for GDUFA fee purposes.

Payment Methods and Deadlines

The FDA accepts payments through several methods. Processing times vary, and missing deadlines has immediate consequences.

Critical Deadline: October 1

Annual facility fees and program fees are due on October 1 of each fiscal year (or the first business day after, if October 1 falls on a weekend). There is a 20-calendar-day grace period—but failing to pay within this window triggers the full range of enforcement consequences.

Self-Identification Deadline: May 1 – June 1

All facilities must self-identify annually between May 1 and June 1. Self-identification data is submitted electronically in Health Level Seven Structured Product Labeling (SPL) format.

Consequences of Non-Compliance

The FDA takes fee compliance seriously. Four major consequences apply to companies that fail to file Form 3794 correctly or pay fees on time.

Consequence 1: Refuse-to-Receive (RTR)

The FDA will not accept any ANDA, PAS, or amendment from a company or its affiliates if fees remain unpaid. This applies even if the specific submission is properly paid—affiliate arrears block all submissions.

Consequence 2: Public Arrears List

Companies that fail to pay within the 20-day grace period are placed on the FDA’s publicly available arrears list. This list is updated regularly and includes parent company names. Business partners, customers, and competitors can all see who is non-compliant.

Consequence 3: Misbranding

Under Section 502(aa) of the FD&C Act, any drug or API manufactured at a non-compliant facility is deemed misbranded. Misbranded products cannot be legally shipped in interstate commerce or imported into the United States.

This consequence is particularly harsh because it affects all products from the facility—not just the application for which fees are owed. Products already on the market become illegal to sell.

Consequence 4: Import Detention

Foreign facilities face additional consequences. The FDA can issue Import Alert 66-76, which allows Detention Without Physical Examination of drugs from non-compliant facilities. Products are refused entry at the border without individual inspections.

Real-World Scenarios: When Form 3794 Matters Most

These scenarios illustrate how Form 3794 requirements affect real business situations. Each shows the action taken and the regulatory outcome.

Scenario 1: The New ANDA Applicant

Situation: GenericCo wants to submit its first ANDA for a generic blood pressure medication in November 2025.

Outcome if compliant: FDA receives ANDA, begins filing assessment, sets goal date.

Outcome if non-compliant: FDA issues RTR; GenericCo must pay all outstanding fees and resubmit, losing months of review time and potentially market position.

Scenario 2: The Foreign API Manufacturer

Situation: An Indian API manufacturer supplies ingredients for five ANDAs held by U.S. companies. The manufacturer has never paid GDUFA fees.

Outcome if non-compliant: All five ANDAs referencing the facility are affected. The FDA places the facility on the arrears list. All APIs manufactured there are deemed misbranded. U.S. customers cannot legally sell products containing those APIs.

The FDA has issued warning letters to foreign facilities for exactly this scenario, including C.P.M. Contract Pharma GMBH & Co. KG in Germany.

Scenario 3: The DMF Holder Timing Issue

Situation: An API supplier receives a request to provide a Letter of Authorization (LOA) for a new customer’s ANDA filing next month. The DMF has never been referenced in a generic submission, so no DMF fee has been paid.

Outcome if timing fails: The ANDA applicant files before the Completeness Assessment finishes. FDA cannot verify DMF adequacy during filing review. The ANDA may be held or RTR’d, damaging the customer relationship.

Mistakes to Avoid

These common errors cause delays, RTR determinations, and financial penalties. Learn from others’ mistakes.

Mistake 1: Submitting Scanned Images of Form 3794

The FDA explicitly states that scanned images of FDA forms will not be accepted. You must use the fillable electronic form from the User Fee System. This error triggers immediate rejection.

Mistake 2: Using the Wrong DUNS Number

The DUNS number must be the “establishment DUNS” for the physical facility location—not the “registrant DUNS” for the corporate headquarters. Mismatches cause processing delays and potential RTR.

Mistake 3: Missing the Wire Transfer PIN

Wire transfer payments must include the Payment Identification Number (PIN). Without it, the payment cannot be matched to your submission, and your invoice amount will be referred to collections.

Mistake 4: Assuming Affiliate Fees Are Separate

If your parent company or any affiliate is on the arrears list, the FDA will not receive your submissions. Companies must verify fee status across their entire corporate family before filing.

Mistake 5: Filing ANDAs Before DMF Fee Payment

When the ANDA relies on a DMF, and the DMF fee has not been paid, the ANDA filing date resets to when the fee is paid. This can push your goal date back months and affect competitive positioning.

Mistake 6: Forgetting Self-Identification

Facilities that manufacture but fail to self-identify face the same misbranding consequences as facilities that fail to pay fees. Self-identification is required annually between May 1 and June 1.

Do’s and Don’ts for Form 3794 Compliance

Key Entities and Their Roles

Understanding who does what helps you navigate the fee system efficiently.

FDA Office of Generic Drugs (OGD)

OGD reviews ANDAs and issues approval decisions. They rely on fee verification before starting substantive review.

FDA User Fee Staff (CDER Collections)

This team processes payments, maintains arrears lists, and resolves fee disputes. Contact them at [email protected] or 301-796-7200.

DMF Holders

DMF holders must pay DMF fees and issue Letters of Authorization. ANDA applicants depend on timely DMF compliance.

Manufacturing Facilities

Every facility manufacturing APIs or FDFs must self-identify and pay facility fees. Their compliance affects all ANDAs that reference them.

ANDA Applicants

Applicants pay ANDA fees and program fees. They must verify that all referenced DMFs and facilities are compliant before submission.

FY 2026 Complete Fee Schedule

The following table shows all GDUFA fees effective October 1, 2025.

Fees increase annually based on FDA’s budget requirements and estimated submission volumes. Planning ahead saves money—companies often rush submissions before October 1 to lock in lower fee rates.

The Completeness Assessment Process for DMFs

When a DMF holder pays the DMF fee, the FDA performs a Completeness Assessment (CA). This process determines whether the DMF contains sufficient information for reference.

The CA evaluates whether:

• The DMF is active
• The fee has been paid
• The DMF has been previously reviewed
• The DMF pertains to a single API
• Administrative information is complete
• Information is sufficient for scientific review
• The DMF is written in English

DMFs that pass the CA appear on the FDA’s public list as available for reference. Failed DMFs receive a GDUFA DMF Incomplete Letter specifying deficiencies.

The FDA recommends paying DMF fees at least three months before ANDA submission to ensure CA completion. For expedited ANDAs, allow even more time.

Electronic Submission Requirements

All ANDA and DMF submissions must be in electronic Common Technical Document (eCTD) format. This requirement is mandatory as of May 5, 2017 for ANDAs and May 5, 2018 for commercial INDs and DMFs.

Form 3794 must be:

• Completed using FDA’s fillable form (not scanned)
• Included in eCTD Module 1 (Administrative Information)
• Submitted through FDA Electronic Submission Gateway for files 10 GB or smaller

The FDA no longer accepts paper DMF submissions. Converting existing paper DMFs to eCTD format is optional but recommended.

Frequently Asked Questions

Does Form 3794 apply to brand-name drug applications?

No. Form 3794 applies only to generic drug submissions under GDUFA. Brand-name drugs use Form FDA 3397, the Prescription Drug User Fee Act (PDUFA) Cover Sheet.

Can I get a fee waiver if my company is a small business?

No. Unlike PDUFA, GDUFA does not provide small business waivers for application fees. The program fee has tiered pricing based on ANDA count, but facility and application fees are the same regardless of company size.

What happens if I submit an ANDA before my DMF holder pays the DMF fee?

Your filing date resets. The FDA will not acknowledge filing until all fee requirements are satisfied. You lose priority position and may miss market entry timing.

Are testing laboratories required to pay GDUFA fees?

No. Facilities that only perform testing, repackaging, or relabeling must self-identify but do not pay facility fees. Only manufacturing facilities pay fees.

How do I check if a facility is on the arrears list?

Yes. The arrears list is publicly available on FDA’s GDUFA website. Check this list before submission to avoid surprises.

Can I transfer a user fee payment to a different application?

Yes. Use Form FDA 3914 to request transfer of user fee payments. The FDA must approve the transfer before it takes effect.

What is the penalty for paying fees after the 20-day grace period?

Public listing and misbranding. Your company appears on the arrears list, you cannot submit applications, and products from non-compliant facilities become illegal to sell.

Do I need to file Form 3794 for Prior Approval Supplements (PAS)?

Yes. PAS submissions require the same fee documentation. If fees are unpaid, the PAS will be deemed received when the fee is paid.

Are PET drugs always exempt from GDUFA fees?

Yes. Positron Emission Tomography drugs are fully exempt from all GDUFA fees, including ANDA fees, DMF fees, and facility fees.

What if my company is acquired mid-fiscal-year?

Fees follow ANDA ownership. The acquiring company assumes fee obligations for all ANDAs acquired. Program fee tier may change based on combined ANDA count.