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`CDER Small Business and Industry Assistance > Frequently Asked Questions on Prescription Drug User Fees (PDUFA)
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`U.S. Food and Drug Administration
`Protecting and Promoting Your Health
`
`Frequently Asked Questions on
`Prescription Drug User Fees (PDUFA)
`
`Introduction
`What is PDUFA?
`Application Fees
`What is a human drug application?
`What is a 505(b)(1) application?
`What is a 505(b)(2) application?
`Establishment Fees
`Product Fees
`Exceptions to Fee Requirements
`Waivers, Reductions, and Refunds
`Payment Information and Procedures
`Procedures for Waiver, Reduction, or Refund Requests
`Additional Information
`
` INTRODUCTION
`
`1. What is PDUFA?
`
`The Prescription Drug User Fee Act (PDUFA), enacted in 1992 and renewed in 1997 (PDUFA II) and 2002
`(PDUFA III) authorizes FDA to collect fees from companies that produce certain human drug and biological
`products. PDUFA established three types of user fees - application fees, establishment fees, and product
`fees. Since the passage of PDUFA, user fees have played an important role in expediting the drug approval
`process.
`
` APPLICATION FEES
`
`2. 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
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`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
`
`table of contents
`
` 3. 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.
`
` 4. 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.
`
`5. What is a supplement?
`
`The 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.
`
`6. What are application fees?
`
`Each person that submits a human drug application or supplement after September 1, 1992, 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-
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`half of a full fee.
`
`Human drug application fees are due when the application or supplement is submitted.
`
`table of contents
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` ESTABLISHMENT FEES
`
`7. What are establishment fees?
`
`Establishment fees are assessed annually of each person who
`
`is named as the applicant in a human drug application and
`had a human drug application or supplement pending after September 1, 1992.
`
`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.
`
`8. 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.
`
`table of contents
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`9. What does final dosage form mean?
`
`Final dosage form means a finished dosage form which is approved for administration to a patient without
`substantial further manufacturing.
`
` PRODUCT FEES
`
`10. What are product fees?
`
`For Fiscal Year 2002 and before:
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`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 for a prescription drug product that has been
`submitted for listing under section 510 of the FD&C Act, and
`had a human drug application or supplement pending after September 1, 1992.
`
`For FY 2003 and after:
`
`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
`had a human drug application or supplement pending after September 1, 1992.
`
`table of contents
`
`11. 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, after October 1, 2002, 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.)
`
`12. What does "listing under section 510 of the FD&C Act" mean?
`
`For user fee assessments, this applies only to FY 2002 and before:
`
`Section 510 of the FD&C Act requires manufacturers, repackers, and relabelers that engage in the
`manufacture, preparation, propagation, compounding or processing of human or veterinary products to
`register their establishments and submit a list of every product in commercial distribution with the FDA.
`Additional information can be found on the Drug Registration and Listing System
`(/Drugs/GuidanceComplianceRegulatoryInformation/DrugRegistrationandListing/default.htm) web
`page.
`
`13. 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.)
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`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
`After October 1, 2002, any large volume parenteral drug product regardless of when it was submitted
`(unless it is a large volume biological product intended for single dose injection for intravenous use or
`infusion)
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`table of contents
`
` EXCEPTIONS TO FEE REQUIREMENTS
`
`14. Are there any exceptions to the fee requirements?
`
`Yes, there are exceptions.
`
`For Application Fees
`
`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.
`
`For Establishment Fees
`
`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.
`
`For Product Fees
`
`Applies only to FY 2002 and before:
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`An annual product fee is not assessed:
`
`if the product is not listed under section 510, or
`if the product listed is the same product as a product approved under
`an application filed under sections 505(b)(2) 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.
`
`After FY 2002
`
`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.
`
`table of contents
`
`15. 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.
`
` WAIVERS, REDUCTIONS, AND REFUNDS
`
`16. Are there any waivers of user fees?
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`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;
`before October 1, 2002 only, assessment of the fee for an application or a supplement filed under section
`505(b)(1) pertaining to a drug product would be inequitable because an application for a product containing
`the same active ingredient filed by another person under section 505(b)(2) could not be assessed user
`fees.
`
`table of contents
`
`17. 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 PDUFA
`(http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/default.htm) web page and look
`under Guidances.
`
`18. Is there a reduction of fees for human drug applications and supplements that are refused for
`filing? Also is there a reduction or refund of fees for human drug applications and supplements that
`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.
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`To be granted a waiver, the human drug applicant must submit a written request for the waiver.
`
`table of contents
`
`19. What is the timeframe for submitting requests for waivers, reductions, and refunds?
`
`To qualify for consideration for a waiver, reduction or refund of any fee, a written request must be submitted
`not later than 180 days after the fee is due. See the Procedures for Waiver, Reduction, or Refund
`Requests section for more information.
`
` PAYMENT INFORMATION AND PROCEDURES
`
`20. How does FDA determine fees?
`
`For FY 1998 through 2002, under the PDUFA II, the human drug application fee rates are set in the statute,
`but are to be adjusted annually for cumulative inflation since FY 1997. Total application fees revenues are
`structured to increase or decrease each year as the number of applications submitted to FDA increases or
`decreases.
`
`For additional information, see the Federal Register notice of January 16, 2002
`(http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=2002_register&docid=fr16ja02-78.pdf),
`"Establishment of Prescription Drug User Fee Rates for Fiscal Year 2002".
`
`For FY 2003 through 2007, under PDUFA III, the fee revenue amounts are set in the statute and are adjusted
`annually for cumulative inflation after FY 2003. After adjustment for inflation, the revenues are also adjusted
`annually to reflect changes in the workload for the process for the review of human drug applications. For
`additional information, see the Federal Register notice establishing Prescription Drug User Fee Rates for
`Fiscal Year 2003 on the PDUFA
`(http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/default.htm) web page, under
`Federal Register Documents.
`
`21. When are user fees due?
`
`For FY 1998 through FY 2002
`
`Application and supplement fees are due when the application or supplement is submitted.
`·Establishment and product fees are payable on or before January 31 of each year.
`FDA issues invoices for establishment and product fees for the fiscal year on or before December 31 of
`each year using the fee schedule for that year.
`
`For FY 2003 through FY 2007
`
`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.
`
`22. What is the Federal government's fiscal year?
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`The Federal government's fiscal year begins on October 1 and ends on September 30.
`
`For example, fiscal year 2002 begins October 1, 2001, and ends September 30, 2002. Fiscal year 2003
`begins October 1, 2002 and ends September 30, 2003.
`
`table of contents
`
`23. What are the instructions for the payment of fees? (updated 2/24/2011)
`
`Payment must be made in U.S. currency by check, bank draft, or U.S. postal money order payable to the
`order of the U.S. Food and Drug Administration. Mail the payment to:
`
`Food and Drug Administration
`P.O. Box 979107
`St. Louis, MO 63197-9000
`
`If checks are sent by a courier that requests a street address, the courier can deliver the checks to the address
`below. 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
`coversheet (http://www.fda.gov/ForIndustry/UserFees/PrescriptionDrugUserFee/ucm119184.htm).
`
` PROCEDURES FOR WAIVER, REDUCTION, OR REFUND REQUESTS
`
`24. 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.
`
`25. Where should I send my request?
`
`If you wish to send us mail (e.g. waiver request, refund request) you can send it to:
`
`1. For US Mail:
`Prescription Drug User Fee Staff
`Food and Drug Administration
`10001 New Hampshire Avenue, Room 3180
`Silver Spring, MD 20993-0002
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`2. For Courier Delivery
`Prescription Drug User Fee Staff
`Food and Drug Administration
`10001 New Hampshire Avenue, Room 3180
`Silver Spring, MD 20903
`
`table of contents
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`26. 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
`
` ADDITIONAL INFORMATION
`
`27. Where can I find additional information about user fees?
`
`There are several guidances that may be helpful.
`
`Classifying Resubmissions in Response to Action Letters ()
`Fees-Exceed-the-Costs Waivers Under the Prescription drug User Fee Act
`(/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm079305.pdf)
`Submitting and Reviewing Complete Responses to Clinical Holds
`(/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm080581.pdf)
`Submitting Separate Marketing Applications and Clinical Data for Purposes of Assessing Fees
`(/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm079320.pdf)
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`Additional information is also available on the FDA User Fees
`(http://www.fda.gov/ForIndustry/UserFees/default.htm) web page.
`
`28. Who should I contact if I still have questions about user fees?
`
`For Drug products, contact Prescription Drug User Fee Staff in the Office of Management, CDER, 301-796-
`7900.
`
`For Licensed Biologic products, contact the Regulatory Information Staff, CBER, 240-402-8177.
`
`Resources for You
`
`Prescription Drug User Fee Act (PDUFA) (/ForIndustry/UserFees/PrescriptionDrugUserFee/default.htm)
`Stay Informed about Small Business
`(/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm270887.htm)
`
`More in CDER Small Business and Industry Assistance
`(/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/default.htm)
`
`About Us (/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm053133.htm)
`
`CDER SBIA Learn (/Drugs/DevelopmentApprovalProcess/SmallBusinessAssistance/ucm483822.htm)
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