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Office of the Commissioner
Office of Management
Office of Financial Management
User Fees

The user fees team develops and maintains all user fee systems (PDUFA, MDUFMA, ADUFA, AGDUFA, MQSA, Color Certification, and Export Certification) for accounts receivables, reports, invoices, and payment processes, receipts and deposits tracking, and data maintenance.

In coordination with the Division of Budget Execution and Control, the user fees team:

Develops allocation and spending plans including rent, other activities, central and program accounts related to user fee programs
Prepares the spending plans for user fee programs, including the PDUFA five-year plan
Prepares cost reporting to ensure the statutory triggers
Monitors staff utilization and completes special analyses as necessary

In coordination with the Office of Management, the user fees team:

Alerts management to any problems and recommends possible management actions pertaining to user fees
Negotiates with the centers and the Office of Regulatory Affairs on spending plans related to user fee triggers
Liaises with industry with questions or concerns about the user fee programs
Prepares answers to Congressional questions and participates in the budget process formulation of the user fee programs
Reviews and analyzes potential impacts of legislative or administrative proposals on user fee programs
Produces legislatively mandated annual financial reports to Congress for PDUFA, MDUFMA, ADUFA, and AGDUFA
Reviews documents for the Agency to assess any impact on the user fee program

Different Types Of User Fees and Their Fee Rates

Animal Drug User Fee Act of 2003 (ADUFA)

The Animal Drug User Fee Act of 2003 (ADUFA), Public Law 108-130, amends the Federal Food, Drug, and Cosmetic Act to establish a program of fees relating to pioneer new animal drugs. The Animal Drug User Fee Amendments of 2008 further amends the FD&C Act to revise and reauthorize the ADUFA program for 2009 – 2013. The ADUFA authorizes the Food and Drug Administration (FDA) to collect fees for certain new animal drug applications, applications for supplements (for which safety or effectiveness data are required), products, establishments, and sponsors. The fees are used to enhance the performance of the new animal drug review process and ensure that new animal drug products are safe and effective for animals as well as for the public with respect to animals intended for food consumption.

For more information about the ADUFA program, please visit: www.fda.gov/cvm/adufa.htm. Or, send your inquiries to cvmadufa@fda.hhs.gov for general questions.

Animal Drug User Fee Rates

Category	FY 2009
Application	$246,300
Application Supplement for Which Safety or Effectiveness Data are Required	$123,150
Establishment	$59,450
Sponsor	$52,700
Product	$4,925

For more information, see Federal Register Notice – Animal Drug User Fee Rates and Payment Procedures for Fiscal Year 2009 | PDF [59 KB]

The Animal Drug User Fee Cover Sheet is available at www.fda.gov/oc/adufa/coversheet.html.

For information regarding financial matters, please contact:
User Fees Financial Support Team
Office of Financial Management (HFA-100)
Food and Drug Administration
5600 Fishers Lane, Rockville, MD 20857
Tel: 301-827-9539 (8:30 am – 5:00 pm, ET)
Email: userfees@fda.gov

Animal Generic Drug User Fee Act of 2008

The Animal Generic Drug User Fee Act of 2008 (AGDUFA), Public Law 110-316, amends the Federal Food, Drug, and Cosmetic Act to establish a program of fees related to generic new animal drugs. The AGDUFA authorizes the Food and Drug Administration (FDA) to collect fees for abbreviated new animal drug applications, products and sponsors. The fees are used to enhance the performance of the generic new animal drug review process and ensure that generic new animal drug products are safe and effective for animals as well as for the public with respect to animals intended for food consumption.

For more information about the AGDUFA program, please visit: www.fda.gov/cvm/AGDUFA.htm. Or, send your inquiries to cvmagdufa@fda.hhs.gov for general questions.

Animal Generic Drug User Fee Rates

Category	FY 2009
Application	$41,400
Sponsor (100%)	$56,350
Sponsor (75%)	$42,265
Sponsor (50%)	$28,175
Product	$3,005

For more information, see Federal Register Notice –Animal Generic Drug User Fee Rates and Payment Procedures for Fiscal Year 2009 | PDF (59 KB)

Color Additive Certification Fees

The establishment of the color additive certification fees, by the Federal Food, Drug, and Cosmetic Act, was to provide, equip, and maintain an adequate certification service for colors. In order to continue to maintain an adequate color certification program to compensate an increase in all costs of operating the program, FDA raised the fees for straight colors and repacks of certified color additive and color additive mixtures in Fiscal Year 2005. Please see Federal Register Notice – Color Additive Certification; Increase in Fees for Certification Services for detailed information. (www.fda.gov/ohrms/dockets/98fr/05-6155.pdf)

For more information about the Color Certification Program, please visit: www.cfsan.fda.gov/~dms/col-toc.html.

Color Additive Certification Fee Rates

Category	Current Rate
Fees for Straight Colors Including Lakes	$0.35 per pound of the batch covered but not less than $224
Repacks of Certified Color, Color Additives and Color Additives mixtures.	(1) 100 lbs. or less – $35 (2) More than 100 lbs. – $35 plus $0.06 for each pound over 100 lbs. and under 1000 lbs (3) More than 1000 lbs. – $89 plus $0.02 for each pound over 1000 lbs

For information regarding the financial matters, please contact:
User Fees Financial Support Team
Office of Financial Management (HFA-100)
Food and Drug Administration
5600 Fishers Lane, Rockville, MD 20857
Tel: 301-827-9539 (8:30 am – 5:00 pm, ET)
Email: userfees@fda.gov

Export Certificate Fees

Section 801(e)(4)(B) of the Federal Food Drug and Cosmetic Act authorizes FDA to collect user fees for export certificates for human drugs, animal drugs and devices. The fees, authorized under the FDA Export Reform and Enhancement Act of 1996, allow the Food and Drug Administration (FDA) to partially recover its costs for personnel, equipment, supplies, printing and overhead. The legislation caps the fee at $175 per certificate.

For more information about the Export Certificate Program, please visit www.fda.gov/cber/gdlns/exprtcert.htm.

Export Certificate Fee Rates:

CBER

$175 for the first certificate
$175 for the second certificate for the same product(s) issued in response to the same request
$85 for each subsequent certificate for the same product(s) issued in response to the same request

CVM

$175 for the first certificate;
$155 for the second certificate for the same products(s) issued in response to the same request;
$70 for each subsequent certificate for the same product(s) issued in response to the same request.

CDER

$175 for the first certificate
$90 for the second certificate with attachments for the same product(s) issued in response to the same request
$40 for any subsequent certificates with attachments for the same products(s) issued in response to the same request

CDRH

$175 for the first certificate
$15 for any subsequent certificates issued for the same products(s) in response to the same request.

Mammography Quality Standards Act of 1992 (MQSA)

The Mammography Quality Standards Act (MQSA) of 1992 (Public Law 102-539) and the subsequent reauthorization Act require the Food and Drug Administration (FDA) to assess and collect fees from mammography facilities to cover the costs of inspections.

The current FDA MQSA inspection fee for a mammography facility with one unit is $1749 to $2,150 for inspections. An additional unit is $250 each. The fee for a follow-up inspection is $991 to $1,144. Facilities in Certifying States (Iowa and Illinois) should contact their State Certifying Agency to determine if the fees apply to them. The current fee FDA assesses on facilities operating within approved Certifying States (Iowa and Illinois) is $548. The option of grouping inspections for a fee discount continues for eligible mammography providers.

For additional information, see the Federal Register notice (72 FR 37027) published on July 6, 2007.

For more information about the MQSA program, please visit: www.fda.gov/cdrh/mammography/index.html.

MQSA Inspection Fee Rates

Table 1 - Annual* Inspection Fee by Number of Units ($250 each for additional unit)

Number of Units	Current Fees
1	$2,150
2	$2,400
3	$2,650
4	$2,900
5	$3,150
6	$3,400
7	$3,650
Follow-up Inspection Fee	$1,144
Facilities Operating Within Approved Certifying States (Iowa and Illinois)	$548

* Facilities selected for participation in the Inspection Demonstration Project authorizing biannual inspections pay this fee, as well.

Medical Device User Fee and Modernization Act of 2002 (MDUFMA)

The Medical Device User Fee and Modernization Act of 2002 (MDUFMA), Public Law 107-250, amends the Federal Food, Drug, and Cosmetic Act to provide the Food and Drug Administration (FDA) important new responsibilities, resources, and challenges. MDUFMA was signed into law on October 26, 2002. It has three particularly significant provisions:

User fees for premarket reviews.
Establishment inspections may be conducted by accredited persons (third-parties).
New regulatory requirements for reprocessed single-use devices.

Under MDUFMA, an application fee must be paid when certain device applications are submitted. Fee-paying applications include premarket applications (PMAs), product development protocols (PDPs), premarket reports (PMRs), modular PMAs, biologics license applications (BLAs), and certain supplements to all of them, as well as premarket notification submissions (510(k)'s).

The Medical Device User Fee Stabilization Act of 2005, P.L. 109-43, amends the Federal Food, Drug, and Cosmetic Act to adjust medical device user fees. It was signed on August 1, 2005.

Below is a brief summary of the law.

It repeals the fee revenue target amounts for FY 2006 and FY 2007.
It eliminates the inflation, workload, compensating, and final year adjustments of revenues used for setting fees.
It sets the premarket application fee for devices for FY 2006 and FY 2007.
It increases the annual gross receipts or sales threshold to $100 million to qualify for fee discounts or waivers.
And more.

For more information about Medical Device User Fee Stabilization Act of 2005, please visit: http://thomas.loc.gov/bss/d109/d109laws.html, and search for Public Law No. 109-43.

For more information about MDUFMA, and the FY 2009 small business qualification form, please visit: www.fda.gov/cdrh/mdufma/index.html.

Now, the Medical Device User Fee Cover Sheet is available at www.fda.gov/oc/mdufma/coversheet.html.

Medical Device User Fee FY 2009 Rates

Application	Standard Fee	Small Business (Less Than or Equal to $100 million in gross receipts or sales) Fee
Premarket Application (PMA, PDP, BLA, PMR)	$200,725	$50,181
1st premarket application from firms with gross receipts or sales less than or equal to $30 million	Not Applicable	Fee Is Waived
Panel-Track PMA Supplement	$150,544	$37,636
BLA Efficacy Supplement	$200,725	$50,181
180-Day PMA Supplement	$30,109	$7,527
Real-Time PMA Supplement	$14,051	$3,513
30-day Notice	$3,212	$1,606
510(k) Premarket Notification Review	$3,693	$1,847
513 (g) Premarket Notification Response	$2,710	$1,355
Annual fee for periodic reporting on a class III device	$7,025	$1,756

For more information, see Important Information on the Medical Device User Fee Rates for FY2009 at http://www.fda.gov/cdrh/mdufma/FY09UserFee.html.

Prescription Drug User Fee Act of 1992 (PDUFA)

In 1992, Congress passed the Prescription Drug User Fee Act (PDUFA). It was reauthorized by the Food and Drug Modernization Act of 1997, and again by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, which includes the Prescription Drug User Fee Amendments of 2002 reauthorizing user fees through fiscal year 2008. The President signed PDUFA III into law on June 12, 2002.

PDUFA authorizes the Food and Drug Administration (FDA) to collect fees from companies that produce certain human drug and biological products. Any time a company wants the FDA to approve a new drug or biologic prior to marketing. It must submit an application along with a fee to support the review process. In addition, companies pay annual fees for each manufacturing establishment and for each prescription drug product marketed.

For more information about the PDUFA program, please visit: www.fda.gov/cder/pdufa/.

From the beginning of 2005, companies and individuals can visit the FDA's website to complete your Prescription Drug User Fee Coversheet and obtain your user fee payment identification number online. This website will assist the companies and individuals to determine whether a fee is required for an application review. If so, how much fee is required. It also helps the FDA to track the application payments. For additional information, please visit www.fda.gov/oc/pdufa/coversheet.html.

Prescription Drug User Fee Rates

Category	FY 2009
Application Requiring Clinical Data	$1,247,200
Application Not Requiring Clinical Data	$623,600
Application Supplements Requiring Clinical Data	$623,600
Establishment	$425,600
Product	$71,520

For more information, see Federal Register Notice – Prescription Drug User Fee Rates for Fiscal Year 2009.

Freedom of Information Act (FOIA) Fees

The FDA is required to provide information requested in writing or through electronic online rooms. For services provided, there are certain fees to the requestors. The FOIA Handbook explains how to request information and what the fees involved are: http://www.fda.gov/opacom/backgrounders/foiahand.html .

More information on FOIA can be found at http://www.fda.gov/foi/.

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