For Industry

Prescription Drug User Fee Amendments

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Latest News:
  • See below for an important notice about Human Drug Applications transmitted to the FDA during the recent lapse in funding.
  • The FY 2019 Clean-Up Program Fee invoices were emailed Friday, December 14, 2018. Full payment of the invoice is due January 14, 2019. If you do not receive your invoice by December 17, 2018, please contact PDUFA User Fee staff at CDERCollections@fda.hhs.gov.
  • Completed PDUFA VI Deliverables
  • The Prescription Drug User Fees for Fiscal Year 2019 have been published. Please see the table below for the 2019 and 2018 rates.

Human Drug Applications Transmitted to FDA During Lapse in Funding

In the absence of either a full-year FY 2019 appropriation or a Continuing Resolution for FDA, beginning on December 22, 2018 and continuing until the enactment of the Continuing Resolution ("lapse period"), agency operations continued to the extent permitted by law, such as activities necessary to address imminent threats to the safety of human life and activities funded by carryover user fee funds.  During the lapse period all electronic submissions of drug and biologic applications transmitted to FDA through the Gateway were processed into an Electronic Document Room and paper submissions were also processed.  Appropriate Agency personnel evaluated each submission and, if no user fee liabilities were incurred by the submission, it was made available for review by FDA staff.  However, during the lapse period, the FDA did not have legal authority to accept user fees assessed for FY2019.  If user fee liabilities were incurred by a submission during the lapse period, and the full payment satisfying those liabilities was not accepted by the FDA prior to the lapse period, the submission was held as unreviewable until the lapse period ended. For submissions not covered by a user fee program, appropriate agency personnel evaluated the submission, and those submissions involving the safety of human life were reviewed.

If payment of FY 2019 fees was transmitted during the lapse period, such as by sending a check or making a wire transfer, then the FDA held that payment until it could accept it on the first business day after the lapse period ended.  Therefore, fee incurring submissions transmitted to FDA during the lapse period are treated as though they had been transmitted on the first business day that the FDA was once again authorized to accept FY 2019 user fees for those submissions, i.e., January 28, 2019. If the full fee was transmitted to FDA during the lapse period, then the fee obligation for that application is satisfied.   If there is an outstanding fee liability on that date, the FDA will notify the sponsor of its outstanding liability. 

  • For ANDAs transmitted to FDA during the lapse period, the sponsor will have a 20-day window, until February 18, 2019, to pay the fee.  If the fee is satisfied within that 20-day period, and if the ANDA is found otherwise to meet the criteria for receipt, the receipt date will be the first business day on which the FDA reopened, i.e., January 28, 2019.  If the fee is not satisfied within that 20-day period and the ANDA is found to otherwise meet the criteria for receipt, the receipt date for the submission will be set to the date on which that liability is satisfied. This 20-day grace period is provided by statute.
  • For NDAs and BLAs transmitted to FDA during the lapse period, the sponsor will have a 5-day window, until February 1, 2019, to pay the fee.  If the fee is satisfied within that 5-day period, the receipt date will be the first business day after the FDA reopened, January 28, 2019.  If the fee is not satisfied within that 5-day period, the receipt date for the submission will be set to the date on which that liability is satisfied. This 5-day grace period is not provided by statute but reflects FDA’s normal practice.

FY 2019 user fee rates:

User Fee Type

2019

2018

Application Fee - Clinical Data Required  $             2,588,478  $             2,421,495
Application Fee - No Clinical Data Required  $             1,294,239  $             1,210,748
Program Fee  $                 309,915  $                 304,162

The Prescription Drug User Fee Act (PDUFA) was created by Congress in 1992 and authorizes FDA to collect fees from companies that produce certain human drug and biological products. Since the passage of PDUFA, user fees have played an important role in expediting the drug approval process.

PDUFA must be reauthorized every five years, and was renewed in 1997 (PDUFA II), 2002 (PDUFA III), 2007 (PDUFA IV), and 2012 (PDUFA V) and 2017 (PDUFA VI). On August 18, 2017, the President signed into law the Food and Drug Administration Reauthorization Act (FDARA), which includes the reauthorization of PDUFA through September 2022. PDUFA VI will provide for the continued timely review of new drug and biologic license applications.

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.

Supplements with unpaid fees  submitted prior to PDUFA VI will not automatically be considered acceptable for filing once PDUFA VI takes effect in FY 2018.  Applicants may submit a new supplement in FY 2018 under PDUFA VI, which will not incur a supplement fee.

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: If an application
    • 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),

The resubmission of the application for the same product (by the same person) does not require an application fee.

  • 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 Act, is not subject to an application fee unless the application includes an indication for other than a rare disease or condition.
       

What are prescription drug program fees?
Prescription drug product 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 product fee.  

Are there any exceptions to the fee requirements?
Yes, there are. An annual product 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 approved under 
    • was approved under an application files 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.  

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 2019 begins October 1, 2018, and ends September 30, 2019. Fiscal year 2018 begins October 1, 2017 and ends September 30, 2018.

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:
CDERCollections@fda.hhs.gov 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 userfees@fda.gov.
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. The 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? To see if an applicant qualifies for a small business wavier of the biosimilar biological product application fee, they can submit Form FDA 3971 (Small Business Waiver and Refund Request) to CDERCollections@fda.hhs.gov

Who should I contact with questions about how to submit a waiver, refund, or reduction request?
Please contact CDERCollections@fda.hhs.gov with any questions about submitting your request.

Where should I send my request?
If you wish to send us mail (e.g. waiver request, refund request), you can send it to:  

For US Mail:
Prescription Drug User Fee Staff
Food and Drug Administration
10001 New Hampshire Avenue, Room 2185
Silver Spring, MD 20993-0002  

For Courier Delivery
Prescription Drug User Fee Staff
Food and Drug Administration
10001 New Hampshire Avenue, Room 2185
Silver Spring, MD 20903  

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

Questions for the Prescription Drug User Fee staff? Email us at CDERCollections@fda.hhs.gov or call us at 301-796-7900.

Refund or waiver request? Please mail them to:

For US Mail:
Prescription Drug User Fee Staff
Food and Drug Administration
10001 New Hampshire Avenue, Room 2185
Silver Spring, MD 20993-0002  

For Courier Delivery
Prescription Drug User Fee Staff
Food and Drug Administration
10001 New Hampshire Avenue, Room 2185
Silver Spring, MD 20903  

Questions about making a payment or confirming the status of a payment? Email the User Fee Helpdesk at userfees@fda.gov or call 301-796-7200

Questions about Pay.gov? Email them at pay.gov.clev@clev.frb.org or call 800-624-1373.

Questions about the Orange Book? Email them at OrangeBook@fda.hhs.gov

 

Page Last Updated: 02/08/2019
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