FDA Form 3794 is the Generic Drug User Fee Cover Sheet that generic drug manufacturers must complete when submitting applications, paying facility fees, or filing drug master files with the Food and Drug Administration. The Generic Drug User Fee Amendments (GDUFA), codified under Section 744B of the Federal Food, Drug, and Cosmetic Act, mandates these user fees to fund FDA’s review of generic drug applications—and failing to properly complete this form results in automatic rejection of your submission.
The financial stakes are significant. For fiscal year 2026, the ANDA filing fee alone is $358,247—a 10% increase from FY 2025—and a refused-to-receive (RTR) determination means paying this fee twice for resubmission. According to FDA data, approximately 14% of original ANDAs receive RTR determinations, with user fee errors among the top causes.
In this article, you will learn:
📋 How to complete every section of FDA Form 3794 with step-by-step guidance and real examples
💰 The exact FY 2026 fee amounts for ANDAs, DMFs, and facilities—and how to avoid costly overpayments
⚠️ The seven most common mistakes that trigger RTR determinations and how to prevent them
🏭 Self-identification requirements for facilities and the consequences of non-compliance
📝 FAQs addressing exemptions, payment methods, and appeal procedures
What Is FDA Form 3794?
FDA Form 3794 serves as the official payment tracking document connecting your financial obligation to your regulatory submission. The FDA uses this form to verify that applicants have paid required user fees before accepting any abbreviated new drug application (ANDA), prior approval supplement (PAS), Type II drug master file (DMF), or facility registration.
The form generates a unique User Fee Payment Identification Number (PIN) beginning with “GD” that must accompany all payments. Without this PIN referenced on your payment, the FDA cannot match your funds to your submission—potentially triggering arrears status and application rejection.
Who Must Complete Form 3794?
The following entities are required to complete FDA Form 3794:
| Entity Type | When Required | Fee Category |
|---|---|---|
| ANDA Applicants | Each original ANDA or applicable amendment | Application fee |
| PAS Applicants | Original CMC post-approval changes requiring prior approval | Application fee |
| DMF Holders | Type II API DMF before first reference on/after October 1, 2012 | One-time DMF fee |
| Facility Owners | API or FDF facilities in approved generic drug submissions | Annual facility fee |
| Generic Drug Applicants | Annually, based on approved ANDA portfolio | Program fee |
The form is completed online through FDA’s User Fee System, which requires Google Chrome, Mozilla Firefox, or Microsoft Edge browsers.
Understanding GDUFA III Fee Categories
Before completing Form 3794, understanding the fee structure under GDUFA III (effective October 1, 2022, through September 30, 2027) is essential. The FDA publishes updated fee schedules in the Federal Register each July, with new rates taking effect October 1.
FY 2026 GDUFA Fee Schedule
| Fee Category | FY 2025 Rate | FY 2026 Rate | Change |
|---|---|---|---|
| ANDA Application | $321,920 | $358,247 | +$36,327 (+11.3%) |
| Type II API DMF | $95,084 | $102,584 | +$7,500 (+7.9%) |
| Domestic API Facility | $41,580 | $43,549 | +$1,969 (+4.7%) |
| Foreign API Facility | $56,580 | $58,549 | +$1,969 (+3.5%) |
| Domestic FDF Facility | $231,952 | $238,943 | +$6,991 (+3.0%) |
| Foreign FDF Facility | $246,952 | $253,943 | +$6,991 (+2.8%) |
| Domestic CMO Facility | $55,668 | $57,346 | +$1,678 (+3.0%) |
| Foreign CMO Facility | $70,668 | $72,346 | +$1,678 (+2.4%) |
| Large Program Fee (≥20 ANDAs) | $1,891,664 | $1,918,377 | +$26,713 (+1.4%) |
| Medium Program Fee (6-19 ANDAs) | $756,666 | $767,351 | +$10,685 (+1.4%) |
| Small Program Fee (≤5 ANDAs) | $189,166 | $191,838 | +$2,672 (+1.4%) |
The $15,000 differential between domestic and foreign facility fees accounts for additional FDA inspection costs associated with overseas travel.
Step-by-Step Guide: Completing FDA Form 3794
Section 1: General Information (Fields 1-4)
Field 1 – Applicant, Holder, or Owner Name and Address
Enter the legal entity that owns, controls, or represents the submission subject. This field captures the name and address of record—not the physical facility location unless they are identical.
Example: If PharmaCo Inc. owns an ANDA but manufactures at a different facility, Field 1 lists PharmaCo Inc.’s corporate headquarters, not the manufacturing plant.
Field 2 – Representative or U.S. Agent
Provide contact information for the person authorized to respond to FDA questions about the cover sheet. For foreign applicants, holders, or owners, this must be a U.S.-based agent. Include:
- Full name
- Title
- Telephone number
- Email address
Field 3 – Fiscal Year
Select the U.S. government fiscal year (October 1 – September 30) to which payment applies. The fiscal year begins on October 1 of the previous calendar year—meaning October 1, 2025, begins FY 2026.
Field 4 – Generic Drug User Fee Type
Check the appropriate box for your fee type:
| Selection | Proceed To |
|---|---|
| ANDA (Original submission or amendment) | Field 5 |
| Generic Drug Applicant Program | Field 17 |
| Type II API Drug Master File | Field 19 |
| Facility | Field 23 |
Section 2: ANDA/PAS Information (Fields 5-16)
Complete this section only if you selected ANDA or PAS in Field 4.
Field 5 – Application Number for ANDA
Enter the six-digit ANDA number. If your number has fewer than six digits, add leading zeros. For example, ANDA 12345 becomes 012345.
Field 6 – Established Name of Product
Enter the product name as referenced in the application. The FDA uses this for validation when questions arise about payment applications.
Field 7 – Amending ANDA
Indicate “Yes” if you are amending an ANDA already submitted but on which FDA has not taken final official action. This determines whether additional API manufacturing fees apply.
Field 8 – API Manufacturing Information Included
Some ANDA submissions contain API manufacturing information without referencing a Type II API Drug Master File. If your submission includes such information, the Section 744B(a)(3)(F) fee applies.
Field 9 – Quantity of APIs
Enter the number of APIs in your submission that are not contained in Type II API DMFs.
| Submission Type | What to Include |
|---|---|
| Original ANDA | All APIs manufactured by applicant stated in submission |
| ANDA Amendment | Only changes/additions to APIs, excluding those previously stated |
| Original PAS | Only changes/additions to APIs manufactured by applicant |
Fields 10-14 – API Facility Details
For each API, provide:
- Drug substance name (Field 10)
- Facility address, FEI number, and DUNS number (Field 11)
- Which APIs are manufactured at each facility (Field 12)
- Whether Section 744B(a)(3)(F) fee has already been paid (Field 13)
- Previous User Fee Payment ID number if fee was previously paid (Field 14)
Field 15 – PET Drug Exemption
Positron Emission Tomography (PET) drugs are exempt from all generic drug user fees. If your ANDA relates solely to PET drugs, the fee calculation reflects zero.
Field 16 – Non-Commercial/Government Entity
State or federal government entities submitting applications for drugs not distributed commercially qualify for exemption. “Distributed commercially” means any distribution in exchange for financial reimbursement, goods, or services.
Section 3: Generic Drug Applicant Program Fee (Fields 17-18)
Field 17 – Parent Company Name
Enter the name of the parent company that owns and controls its subsidiaries.
Field 18 – Parent Company Tier
The FDA determines your tier based on approved ANDAs:
| Tier | Approved ANDAs | FY 2026 Fee |
|---|---|---|
| Large | 20 or more | $1,918,377 |
| Medium | 6-19 | $767,351 |
| Small | 5 or fewer | $191,838 |
Critical: Affiliates’ ANDAs count toward the parent company’s total. If Company A (4 ANDAs) is affiliated with Company B (16 ANDAs), they collectively reach 20 ANDAs and must pay one large fee.
Section 4: Drug Master File Information (Fields 19-22)
Field 19 – Type II API Drug Master File Number
Enter the DMF number, which the DMF holder provides. Only Type II API DMFs referenced in generic drug submissions trigger fee obligations.
Field 20 – Name of Drug Substance
Provide the drug substance name covered by the Type II API DMF.
Field 21 – PET Drug Exemption
Same exemption rules apply as Field 15.
Field 22 – Non-Commercial/Government Entity
Same exemption rules apply as Field 16.
Section 5: Facility Information (Fields 23-25)
Field 23 – U.S. Facility
Indicate whether the facility is located in the United States, its territories, or possessions. This determines whether domestic or foreign fee rates apply.
Field 24 – Facility Name, Address, FEI, and DUNS Number
Provide:
- Official facility name
- Physical address
- FDA Establishment Identifier (FEI)—a unique 7- or 10-digit identifier issued by FDA’s Office of Regulatory Affairs
- DUNS Number—the 9-digit identifier issued by Dun & Bradstreet for the physical facility location
Important: Use the establishment DUNS, not the registrant DUNS.
Field 25 – Type of Facility
Indicate what the facility produces for human generic drugs:
| Facility Type | Description | FY 2026 Domestic Fee | FY 2026 Foreign Fee |
|---|---|---|---|
| API | Active pharmaceutical ingredients | $43,549 | $58,549 |
| FDF | Finished dosage forms | $238,943 | $253,943 |
| CMO | Contract manufacturing (FDF not owned by applicant) | $57,346 | $72,346 |
| API + FDF | Both operations | FDF fee only | FDF fee only |
Real-World Scenarios: FDA Form 3794 in Action
Scenario 1: First-Time ANDA Submission
Maria’s Generic Pharmaceuticals is submitting its first ANDA for a generic blood pressure medication. The company manufactures its own API at a domestic facility.
| Step | Action | Consequence |
|---|---|---|
| Complete Field 4 | Select “ANDA (Original submission)” | Directs to ANDA information section |
| Complete Field 8 | Mark “Yes” for API manufacturing information included | Triggers Section 744B(a)(3)(F) fee |
| Complete Field 9 | Enter “1” for quantity of APIs | Fee calculation includes API information fee |
| Pay ANDA fee + API fee | $358,247 + $102,584 = $460,831 | Submission can proceed |
| Submit signed Form 3794 | Include in first volume with Form FDA 356h | FDA receives complete application |
Outcome: Maria’s application is received for review within the GDUFA goal timeline.
Scenario 2: DMF Holder Referencing New ANDA
API Solutions Ltd. (a foreign company) holds a Type II DMF that will be referenced for the first time by another company’s ANDA.
| Step | Action | Consequence |
|---|---|---|
| Complete Field 4 | Select “Type II API Drug Master File” | Directs to DMF information section |
| Complete Field 19 | Enter DMF number | Links payment to correct file |
| Complete Field 2 | Provide U.S. agent information (required for foreign holders) | FDA has domestic contact |
| Pay DMF fee | $102,584 (FY 2026) | DMF becomes “available for reference” |
Critical Timing: FDA recommends paying the DMF fee at least 6 months before the referencing ANDA submission to ensure completeness assessment is finished.
Scenario 3: Medium-Sized Company Annual Program Fee
GeneriPharma Inc. owns 12 approved ANDAs and has an affiliate with 3 approved ANDAs.
| Step | Action | Consequence |
|---|---|---|
| Calculate combined ANDAs | 12 + 3 = 15 ANDAs | Medium tier (6-19) |
| Complete Field 4 | Select “Generic Drug Applicant Program” | Directs to program fee section |
| Complete Field 17 | Enter parent company name | Links affiliates |
| Pay program fee | $767,351 (Medium tier, FY 2026) | All products remain properly branded |
Consequence of Non-Payment: Failure to pay within 20 days of the due date results in:
- Placement on publicly available arrears list
- New ANDAs submitted by applicant or affiliates not received
- All marketed drugs deemed misbranded
Common Mistakes to Avoid
1. Using Incorrect DUNS Numbers
The Error: Entering the registrant DUNS instead of the establishment DUNS for the physical facility location.
The Consequence: FDA cannot verify facility identity, potentially triggering self-identification compliance issues and delayed processing.
Prevention: Verify DUNS numbers directly with Dun & Bradstreet and confirm the number corresponds to the physical facility address, not corporate headquarters.
2. Missing the FEI Number
The Error: Submitting Form 3794 without the FDA Establishment Identifier for facilities.
The Consequence: Form validation fails, and facility fees cannot be properly assessed.
Prevention: If you don’t have an FEI number, contact [email protected] before submission.
3. Paying the Wrong Fee Amount
The Error: Using prior fiscal year fee rates when submitting after October 1.
The Consequence: Underpayment triggers a 5-day warning; if not resolved, the application is deemed unacceptable for filing.
Prevention: Always verify current fee rates on the FDA GDUFA website before submitting payment.
4. Failing to Include API Information Fees
The Error: Submitting an ANDA with API manufacturing information without paying the Section 744B(a)(3)(F) fee when not referencing a Type II DMF.
The Consequence: Application refused for receipt.
Prevention: If your ANDA contains any API manufacturing information not in a referenced DMF, calculate additional API/facility combination fees.
5. Missing the Payment PIN on Wire Transfers
The Error: Sending wire transfer payment without including the User Fee Payment ID Number (PIN).
The Consequence: FDA cannot match payment to cover sheet, and application may be deemed incomplete.
Prevention: Include the PIN (beginning with “GD”) in the wire transfer reference field.
6. Not Accounting for Affiliates in Program Fees
The Error: Paying small-tier program fee when affiliated companies’ combined ANDAs push the portfolio into a higher tier.
The Consequence: Company placed on arrears list, products deemed misbranded.
Prevention: Submit affiliate information via the CDER Direct NextGen Collaboration Portal by April 1 each year.
7. Submitting After the Fiscal Year Deadline Without New Cover Sheet
The Error: Using an FY 2025 cover sheet for a submission after October 1, 2025.
The Consequence: Fee amounts are incorrect; application processing delayed.
Prevention: Generate new cover sheets in the User Fee System after October 1 for the new fiscal year.
Do’s and Don’ts
Do’s
| Do | Why |
|---|---|
| Verify FEI and DUNS numbers before submission | Incorrect identifiers cause processing delays and potential RTR |
| Pay fees at least 30 days before ANDA submission | Ensures payment clears and is matched to cover sheet before FDA receipt |
| Include signed Form 3794 with Form FDA 356h | Requirement for complete ANDA submissions |
| Self-identify facilities between May 1 and June 1 annually | Failure to self-identify renders products misbranded |
| Request refunds within 180 days if fee paid in error | Statutory deadline for refund requests under Section 744(m) FD&C Act |
Don’ts
| Don’t | Why |
|---|---|
| Submit partial payments online | Pay.gov only accepts full payments; partial payments require alternative methods |
| Assume discontinued ANDAs don’t count for program fees | Discontinued ANDAs remain “approved” for user fee purposes until officially withdrawn |
| Wait until fee due date to pay facility fees | Facility arrears block new submissions from all affiliates |
| Create new FURLS accounts if you already have one | Creates duplicate records preventing access to current registrations |
| Ignore affiliate relationships when calculating program fees | Single program fee required for all affiliated entities |
Pros and Cons of the GDUFA Fee System
Pros
| Advantage | Explanation |
|---|---|
| Predictable review timelines | GDUFA III establishes specific goal dates for FDA review actions |
| Enhanced communication | Discipline Review Letters communicate deficiencies earlier in the review cycle |
| Transparent fee structure | Published Federal Register notices provide advance notice of fee changes |
| Pre-ANDA programs | Applicants can obtain FDA feedback before submission, reducing RTR risk |
| DMF completeness assessments | Fee payment triggers FDA review, making DMFs “available for reference” |
Cons
| Disadvantage | Explanation |
|---|---|
| High financial barriers | FY 2026 ANDA fee of $358,247 creates entry barriers for smaller manufacturers |
| Annual fee increases | Fees have risen consistently, with FY 2026 application fees up 11.3% |
| Complex affiliate calculations | Determining program fee tiers requires tracking all affiliate ANDAs |
| Foreign facility surcharges | $15,000 additional fee for foreign facilities |
| Arrears consequences severe | Non-payment renders all products misbranded, a federal violation |
Key Entities and Their Roles
Food and Drug Administration (FDA)
The FDA’s Center for Drug Evaluation and Research (CDER) reviews ANDAs and manages the GDUFA program. The Office of Generic Drugs (OGD) conducts technical reviews, while the Office of Financial Management (OFM) processes user fee payments.
Office of Regulatory Affairs (ORA)
Issues FDA Establishment Identifier (FEI) numbers and conducts facility inspections. Contact [email protected] for FEI inquiries.
Dun & Bradstreet
Issues DUNS numbers required for facility identification on Form 3794. Visit dnb.com to obtain or verify numbers.
User Fees Helpdesk
FDA’s primary contact for Form 3794 questions. Reach them at 301-796-7200 or [email protected].
FAQs
Can I get a refund if FDA refuses to receive my ANDA?
Yes. FDA will refund 75% of the application fee if your ANDA receives an RTR determination. You must submit a refund request at userfees.fda.gov/fdarefund within 180 days.
Do I need to pay a DMF fee every time someone references my DMF?
No. The DMF fee is a one-time payment, incurred on first reference after October 1, 2012, or when you request the initial completeness assessment—whichever occurs earlier.
Are state government applications exempt from GDUFA fees?
Yes. State or federal government entities submitting applications for drugs not distributed commercially qualify for exemption from all GDUFA fees.
Can my affiliate pay our program fee on our behalf?
Yes. Either the parent company or any affiliated company can pay the single program fee required for all affiliates.
What happens if I miss the facility fee deadline?
No. Missed deadlines result in immediate placement on the arrears list. All facility products become misbranded, and no new submissions referencing that facility will be received.
Do I need to self-identify if my facility only does testing?
Yes. Sites conducting CGMP-required testing must self-identify but are not required to pay facility fees. Research-only testing sites are excluded.
Can I pay GDUFA fees by check?
No. Effective October 1, 2025, FDA no longer accepts paper-based payments. Payments must be made via electronic check (ACH), credit card, or wire transfer.
Is there a penalty for late facility fee payment?
Yes. Late payment triggers arrears status, public listing, rejection of new submissions, and misbranding of all products manufactured at that facility.
Do discontinued ANDAs count toward my program fee tier?
Yes. Discontinued ANDAs remain “approved” for user fee calculations unless officially withdrawn by April 1 of the previous fiscal year.
What if my company acquires another company mid-year?
No. FDA uses information effective as of October 1 to determine program fee tier. Mid-year acquisitions affect the following fiscal year’s tier calculation.