For Industry

Prescription Drug User Fee Act (PDUFA)

Latest News:
  • In preparation for our annual FY 2017 PDUFA invoices, our “Dear Colleague Letter” (DCL) was emailed on Thursday, May 05, 2016. Please submit your response by Friday, June 10, 2016. If you have any questions regarding the DCL, please send an email to the Dear Colleague Coordinator at CDERCollections@fda.hhs.gov or call 301-796-7900. Please see link to Dear Colleague Letter in the “Related Info/PDUFA Letters” section. (posted 5/5/2016)
  • The FY 2016 user fee rates have been published (posted 8/3/2015):
Application w/Clinical $2,374,200
Application w/o Clinical $1,187,100
Supplement w/Clinical $1,187,100
Product $114,450
Establishment $585,200

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). On July 9, 2012, the President signed into law the Food and Drug Administration Safety and Innovation Act (FDASIA), which includes the reauthorization of PDUFA through September 2017. PDUFA V 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)(1) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) after September 1, 1992
  • approval of a new drug submitted under section 505(b)(2) of the FD&C Act after September 30, 1992, which requests approval of
    • a molecular entity which is an active ingredient (including any salt or ester of an active ingredient), or
    • an indication for a use that had not been approved under an application submitted under section 505(b), or
  • licensure of certain biological products under section 351 of the Public Health Service Act (PHS Act) submitted after September 1, 1992.”

What is a 505(b)(1) application?
A 505(b)(1) application is an application that contains full reports of investigations of safety and effectiveness.

The investigations the applicant relied on for approval were conducted by or for the applicant or the applicant has obtained a right of reference or use for the investigations.

What is a 505(b)(2) application?
A 505(b)(2) application is an application submitted under section 505(b)(1) for which

  • the investigations the applicant relied on for approval were not conducted by or for the applicant, and
  • the applicant has not obtained a right of reference or use for the investigations (21 U.S.C. 355(b)(2)).

Section 505(b)(2) expressly permits FDA to rely, for approval of an NDA, on data not developed by the applicant - such as published literature or the agency's finding of safety and/or effectiveness of a previously approved drug product.

What is a supplement?
Federal Food, Drug, and Cosmetic Act (FD&C Act) says, "The term supplement means a request to the Secretary to approve a change in a human drug application which has been approved." Each indication or claim is considered a separate change for which a separate supplement should be submitted. This policy allows FDA to approve each indication or claim as it is ready for approval, rather than delaying approval until the last of a group of indications or claims is ready to be approved.

What are application fees?
Each person that submits a human drug application or supplement 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. 
  • A supplement to 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 one-half of a full fee.

Human drug application fees are due when the application or supplement 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 or Supplements: If an application or supplement
    • was submitted by a person that paid the fee for the application or supplement,
    • was accepted for filing, and
    • was not approved or was withdrawn (without a waiver),

The resubmission of the application or supplement 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.
    • A supplement proposing to include a new indication for a rare disease or condition is not subject to an application fee if the drug has been designated a drug for a rare disease or condition with regard to the indication proposed in the supplement.

What are establishment fees?
Establishment fees are assessed annually of each person who

  • is named as the applicant in a human drug application and
  • has a human drug application or supplement pending.

An establishment fee is assessed for each prescription drug establishment listed in the approved human drug application as an establishment that manufactures the prescription drug product.

  • The establishment fee is assessed for each prescription drug product that is assessed a product fee - unless the establishment listed in the application does not manufacture the product during the fiscal year.
  • Each establishment is assessed only one establishment fee for a fiscal year.
  • If more than one applicant lists an establishment in a human drug application, the establishment fee for the fiscal year is divided equally among the applicants whose prescription drug products are manufactured at the establishment.

What is a prescription drug establishment?
The term prescription drug establishment means a foreign or domestic place of business

  • which is at one general physical location consisting of one or more buildings, all of which are within 5 miles of each other, and
  • at which one or more prescription drug products are manufactured in final dosage form.

For purposes of user fees, the term manufactured does not include packaging.

What does final dosage form mean?
Final dosage form means a finished dosage form that is approved for administration to a patient without substantial further manufacturing.

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

Are there any exceptions to the fee requirements?

  • If the establishment listed in the human drug application does not engage in the manufacture of the prescription drug product during the fiscal year, the applicant is not assessed an establishment fee.
  • When the manufacture of a prescription drug is started during the year and after the establishment fee has already been assessed, the applicant is not assessed an establishment fee for that year. The product must not have been manufactured at the establishment in the previous fiscal year to be exempt.

What are product fees?
Prescription drug product fees are assessed annually for eligible products. The product fees are assessed on products for each person who

  • is named as the applicant in a human drug application, and
  • has a human drug application or supplement pending.  

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. (Section 351 of the PHS Act provides the authority for regulating biological products. Biological products are regulated by the Center for Biologics Evaluation and Research.)

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 (Section 351 of the PHS Act provides the authority for regulating biological products. Biological products are regulated by the Center for Biologics Evaluation and Research.)
  • 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
  • A large volume parenteral drug product approved before September 1, 1992
  • Any large volume parenteral drug product unless it is a large volume biological product intended for single dose injection for intravenous use or infusion
     

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 product is not on the list compiled under section 505(j)(7)(A) (Prescription Drug Product List (the active portion) in the Approved Drug Products with Therapeutic Equivalence Evaluations (the Orange Book)), or
  • if the product is listed in the Orange book with a potency described in terms of per 100 mL, or,
  • if the product listed is the same product as another product approved under 
    • an application filed under sections 505(b) or 505(j) of the FD&C Act,
    • an abbreviated application filed under section 507 of the Act (as in effect on the day before the date of enactment of the Food and Drug Administration Modernization Act of 1997), or,
    • an abbreviated new drug application prior to the implementation of the Drug Price Competition and Patent Term Restoration Act of 1984.
       

What is a 505(j) application?
A 505(j) application is an abbreviated new drug application (ANDA) that contains information to show that the proposed product is identical in active ingredient, dosage form, strength, route of administration, labeling, quality, performance characteristics and intended use, among other things, to a previously approved product - the reference listed drug (RLD).

  • ANDAs do not contain clinical studies as required in NDAs but are required to contain information establishing bioequivalence to the RLD.
  • In general, the bioequivalence determination allows the ANDA to rely on the Agency's finding of safety and efficacy for the RLD.
  • A drug product that is the subject of an ANDA is referred to as a generic drug.

When are user fees due?

  • Application and supplement fees are due when the application or supplement is submitted.
  • Establishment and product fees are payable on or before October 1 of each fiscal year.
  • FDA issues invoices for establishment and product fees for the coming fiscal year in August of each year using the fee schedule for the coming 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 2016 begins October 1, 2015, and ends September 30, 2016. Fiscal year 2017 begins October 1, 2016 and ends September 30, 2017.  

What are the instructions for the payment of fees?
A payment may be submitted electronically via the User Fees Payment Portal or by check, bank draft, U.S. postal money order, or 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. Mail the payment to:

Food and Drug Administration
P.O. Box 979107
St. Louis, MO 63197-9000

If checks are sent by a courier requesting a street address, the courier can deliver the checks to the address below. Please note: This address is for courier delivery only.

U.S. Bank
Attn: Government Lockbox 979107
1005 Convention Plaza
St. Louis, MO 63101  

Include the user fee I.D. number (for application and supplement submissions only), the BLA/NDA number, or the invoice number and the FDA P.O. Box number 979107 on the enclosed check or in the documentation that comes with the payment.  

It would be helpful to include either 1) the user fee cover sheet (Form FDA 3397) for application or supplement fee payments, or 2) the invoice cover sheet for annual product or establishment fees.  

UFID Numbers for application and supplement submissions are obtained by completing the online User Fee Cover Sheet.

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
  • the fees will exceed the anticipated present and future costs incurred by FDA for conducting the process for the review of the new drug applications for the person

Are there any waivers of fees specifically for small businesses?
Yes. The Agency will waive the application fee for the first human drug application that a small business or its affiliate submits for review (section 736(d)(1)(E) of the FD&C Act).

  • the term small business is defined as a business that has fewer than 500 employees, including employees of affiliates.
  • an affiliate is a business entity that has a relationship with a second business entity if one business entity controls, or has the power to control, the other business entity, or a third party controls, or has the power to control, both entities. (Section 735(9) of the FD&C Act).

To be granted a waiver, the small business must submit a written request for the waiver.
After a waiver for a first human drug application is granted, the small business is assessed appropriate user fees for all subsequent human drug applications and supplements submitted for review.
There are no small business waivers for product or establishment fees.
For additional information on user fee waivers, go to the Guidance Documents & MAPPs link in the Related Info tab.  

Is there a reduction of fees for human drug applications and supplements 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 or supplement that is refused for filing or is withdrawn before filing.
  • if an application or supplement 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.  

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 3179
Silver Spring, MD 20993-0002  

For Courier Delivery
Prescription Drug User Fee Staff
Food and Drug Administration
10001 New Hampshire Avenue, Room 3179
Silver Spring, MD 20903  

What information should I include in my request?
The written request should include the following information:

  • the name and address of the entity, including the company name, and the name and telephone number of the contact person for the fee waiver or reduction request
  • identification of the specific fee for which a waiver, refund, or reduction is requested
  • for an application or supplement fee - the application or supplement number for which the waiver, refund, or reduction is requested; the date the application was submitted; and whether the application requires clinical data for approval
  • for product fees - the name of the product (generic and brand names), the application number, the name of the applicant, the specific strength or potency of the product, the dosage form, the invoice number, and the invoice date
  • for establishment fees - the name and address of the establishment for which the waiver or reduction is requested, the establishment number as listed on the invoice, the invoice number, and the invoice date
  • the statutory provision under which the waiver or reduction is requested
  • information and analyses demonstrating that the criteria for the waiver, refund, or reduction of fees are met
  • date on which payment was or will be made to FDA of the fee for which a waiver or reduction is requested
  • for establishment and/or product fees - a copy of the fee invoice sent by FDA

Questions for the Prescription Drug User Fee staff? Email us at CDER-PDUFA@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 3179
Silver Spring, MD 20993-0002  

For Courier Delivery
Prescription Drug User Fee Staff
Food and Drug Administration
10001 New Hampshire Avenue, Room 3179
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 DrugProducts@cder.fda.gov

 

Page Last Updated: 07/20/2016
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