Federal Register Documents

• Fee Rate for Using a Rare Pediatric Disease Priority Review Voucher in Fiscal Year 2022
• Fee Rate for Using a Tropical Disease Priority Review Voucher in Fiscal Year 2022 
• Fee Rate for Using a Material Threat Medical Countermeasure Priority Review Voucher in Fiscal Year 2022 
• Genus Medical Technologies LLC Versus Food and Drug Administration; Request for Information and Comments 
• Establishment of Prescription Drug User Fee Rates for Fiscal Years 1998 – present

Guidances

• Guidance Documents and MAPPs

To find older Federal Register Documents, please visit the Archive Page.

What is a human drug application?
PDUFA levies a user fee on certain human drug applications. Under PDUFA, the term human drug application means an application for

• approval of a new drug submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), or
• licensure of certain biological products under section 351(a) of the Public Health Service Act (PHS Act).

What are application fees?
Each person that submits a human drug application is assessed an application fee as follows:

•  A human drug application for which clinical data (other than bioavailability or bioequivalence studies) with respect to safety or effectiveness are required for approval is assessed a full application fee.
•  A human drug application for which clinical data with respect to safety or effectiveness are not required for approval is assessed one-half of a full fee.

Human drug application fees are due when the application is submitted.

How do I pay a fee?
Visit our Payment Information and Cover Sheet tab for all the information you will need to pay your application fee.

Are there any exceptions to the fee requirements?

Previously Filed Applications: 

• An application fee is not required for the resubmission of an application if the original application of the same product 
  • was submitted by a person that paid the fee for the application, 
  • was accepted for filing, and 
  • was not approved or was withdrawn (without a waiver). 

Designated Orphan Drug or Indication  

• An application for a prescription drug product that has been designated as a drug for a rare disease or condition, under section 526 of the FD&C Act, is not subject to an application fee unless the application includes an indication for other than a rare disease or condition. 

For more information about application fees, please read FDA’s guidance for industry Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017.

What are prescription drug program fees?
Prescription drug program fees are assessed annually for eligible products. The program fees are assessed for each prescription drug product that is identified in such a human drug application approved as of October 1st of such fiscal year. 

Applicants may not be assessed more than five prescription drug program fees for a fiscal year for prescription drug products identified in a single approved application.

What is the definition of a prescription drug product?
Prescription drug product means a specific strength or potency of a drug in final dosage form for which a human drug application has been approved and which may be dispensed only by prescription under section 503(b) of the FD&C Act, and is also on the list of products described in section 505(j)(7)(A), or is on a list created and maintained by the Secretary of products approved under human drug applications under section 351 of the Public Health Service Act.

Are there drugs that are not included in the term prescription drug product?
Yes. The term prescription drug product does not include the following drugs:

• Whole blood or a blood component for transfusion,
• A bovine blood product for topical application licensed before September 1, 1992, an allergenic extract product, or an in vitro diagnostic biologic product licensed under section 351 of the PHS Act,
• A biological product that is licensed for further manufacturing use only,
• A drug that is not distributed commercially AND is the subject of an application or supplement submitted by a State or Federal Government entity.

How do I pay a fee?
Visit our Payment Information and Cover Sheet tab for all the information you will need to pay your program fee.  

Are there any exceptions to the fee requirements?
Yes, there are. An annual program fee is not assessed if the prescription drug product is:

•  listed in the Orange Book with a potency described in terms of per 100 mL, or,
•  the same product as another product that – 
  • was approved under an application filed under sections 505(b) or 505(j) of the FD&C Act,
  • is not in the list of discontinued products compiled under section 505(j)(7) of the FD&C Act.   

For more information about program fees, please read FDA’s guidance for industry Assessing User Fees Under the Prescription Drug User Fee Amendments of 2017.

When are user fees due?

• An application fee is due when the application is submitted to FDA.
• FDA issues invoices for annual program fees for the coming fiscal year in August of each year using the fee schedule for the coming fiscal year. Payments are due either on the first business day on or after October 1 of each fiscal year or the first business day after the enactment of an appropriations Act providing for the collection and obligation of fees for that fiscal year, whichever occurs later.
• FDA may issue additional invoices as needed. These invoices are also known as clean-up invoices to capture program fees that were not previously invoiced. The clean-up invoices are generally issued in mid-December of the fiscal year and the fees are generally due by mid-January of the fiscal year.

What is the Federal government's fiscal year?
The Federal government's fiscal year begins on October 1 and ends on September 30.  For example, fiscal year 2022 begins October 1, 2021, and ends September 30, 2022. 

What is the PDUFA User Fee Cover Sheet?
Form FDA 3397, the PDUFA user fee cover sheet, is designed to provide the minimum necessary information to determine whether a fee is required for review of an application, to determine the amount of the fee required, and to help FDA track payments. The PDUFA Cover Sheet Form FDA 3397 should be completed for the following:

• 505(b) and 351(a) Original Applications
• Resubmission of 505(b) and 351(a) Original Application after a Refuse to File
• Resubmission of 505(b) and 351(a) Original Applications Withdrawn before the filing date.

The form provides a cross-reference of the fee submitted for an application with the actual application by using a unique number tracking system to assign the user fee payment identification number (PIN). The information collected is used by FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER) to initiate the administrative screening of new drug applications and biologics license applications. Note: You do not need to fill out a Form 3397 for annual program fee payments.

How do I fill out the PDUFA User Fee Cover Sheet Online?
FDA offers you the ability to complete a PDUFA User Fee Cover Sheet online and submit it electronically. Please visit PDUFA User Fee Coversheet webpage to fill out the form. To fill out the form online, you need Microsoft Internet Explorer 5.5 or higher. For Step-by-Step Instructions on how to fill out the cover sheet, please visit:

https://userfees.fda.gov/OA_HTML/PDUFACScreation.pdf

How do I submit payment after completing the PDUFA User Fee Cover Sheet?
A payment may be submitted electronically via the User Fees Payment Portal or by mailing a check, bank draft, U.S. postal money order, or by wire transfer made payable to the order of the U.S. Food and Drug Administration. For all payment options, the payment must be made in U.S. currency drawn on a U.S. financial institution.

If mailing your payment, please send a printed copy of the completed PDUFA User Fee Cover Sheet along with a check, bank draft, or U.S. Postal money order made payable to the Food and Drug Administration for the fee amount due. Remember to include the user fee payment identification number, beginning with "PD," the BLA/NDA number, and the FDA P.O. Box on the enclosed check.

Mail payment and copy of PDUFA user fee cover sheet to:

Food and Drug Administration
P.O. Box 979107
St. Louis, MO 63197-9000
Note: In no case should payment be submitted with the actual application to CDER/CBER.

If checks are to be sent by a courier that requires a street address, the courier can deliver the checks to:

U.S. Bank
Attn: Government Lockbox 979107
1005 Convention Plaza
St. Louis, MO 63101
Note: This address is for courier delivery only.

Wire Transfer Payment

US Department of Treasury
TREAS NYC
33 Liberty Street
New York, NY 10045
FDA Deposit Account Number: 75060099
US Department of Treasury routing/transit number: 021030004
SWIFT Number: FRNYUS33
Beneficiary: FDA
8455 Colesville Road
COLE-14-14253
Silver Spring, MD 20993-0002

Note: For wire transfers, please include the user fee payment identification number (PIN), beginning with "PD", the BLA/NDA number and ensure that the fee that your bank will charge for the wire transfer is added to your fee payment.

Please note for payments for annual program fees, it is helpful to include the invoice sheet that was sent to you for the annual program fees (or product or establishment fees).

If you have problems or if you are unsure on whether or not you need to file an application with FDA or are unsure what type of application to file:

Prescription Drug User Fee Staff Contact:
[email protected] or 301-796-7900

Center for Biologics Evaluation and Research Contact:
Carla Vincent at 240-402-8177

If you need technical assistance with your cover sheet or are unsure how to proceed:

Contact: FDA User Fee Financial Support Team at (301) 796-7200 or [email protected].
PDUFA User Fee Cover Sheet
OMB No. 0910-0297
Form FDA 3397 (03/19)

Are there any waivers of user fees?
Under section 736(d) of the FD&C Act, a waiver may be granted for one or more fees where:

• a waiver or reduction is necessary to protect the public health
• assessment of the user fees would present a significant barrier to innovation due to limited resources or other circumstances, or
• the applicant involved is a small business submitting its first human drug application for review

Is there a reduction of fees for human drug applications that are refused for filing or are withdrawn before or after filing?
Yes. The following reductions or refunds are available:

• 75 percent of the application fee is refunded for any application that is refused for filing or is withdrawn before filing.
• if an application is withdrawn after it is filed, FDA may refund the fee or a portion of the fee if no substantial work was performed on the application or supplement. FDA has the sole discretion to refund a fee or a portion of the fee. FDA's determination concerning a refund is not reviewable.

To be granted a waiver, the human drug applicant must submit a written request for the waiver.  

What is the timeframe for requesting a waiver, reduction, or refund of fees?
To qualify for consideration, a written request for waiver, reduction or refund must be submitted not later than 180 days after such fee is due.

How do I request a small business waiver and refund? An applicant should submit Form FDA 3971 (Small Business Waiver and Refund Request) to [email protected] to see if they qualify for a small business waiver. 

Who should I contact with questions about how to submit a waiver, refund, or reduction request?
Please contact [email protected] with any questions about submitting your request.

Where should I send my request?
Please submit a refund or waiver request by electronic mail to the Prescription Drug User Fee staff at [email protected].

What information should I include in my request?
For more information about submitting a request for a waiver, refund or reduction request, please read FDA’s guidance for industry User Fee Waivers, Reductions, and Refunds for Drug and Biological Products.

• PDUFA VII: Fiscal Year 2023 - 2027
• PDUFA VI Five-Year Financial Plan (PDF - 480 KB) 
• PDUFA Meetings 
• PDUFA VI Information Technology Goals and Progress
• PDUFA VI: Fiscal Years 2018 - 2022
• Federal Register Notice: Public Meeting on Proposed Recommendations for PDUFA Reauthorization
• PDUFA VI Proposed Commitment Letter
• PDUFA V: Fiscal Years 2013-2017 

• CDER & CBER Net Hiring Data
• PDUFA 5 Year Financial Plan (2018) (PDF - 540KB)
• PDUFA Letters
• Annual Reports and Plans
• Orange Book
• CDER Therapeutic Biologic Products List 
• CBER Billable Biologics List
• PDUFA User Fee Rates Archive
• Complete Response Letter Final Rule
• PDUFA Financial Reports
• PDUFA Performance Reports

Questions for the Prescription Drug User Fee staff? Contact us at [email protected] or 301-796-7900.

Refund or waiver request? Please email them to [email protected].

Questions about making a payment or confirming the status of a payment? Email the User Fee Helpdesk at [email protected] or call 301-796-7200.

Questions about Pay.gov? Email them at [email protected] or call 800-624-1373.

Questions about the Orange Book? Email them at [email protected].

In the rare instance where you are unable to submit an electronic request, you may mail your request, via the carrier of your choice, to FDA, Division of User Fee Management, 10001 New Hampshire Ave, Silver Spring, MD 20993.