Regulatory Focus™ > News Articles > FDA Publishes All User Fee Rates for Fiscal Year 2014

FDA Publishes All User Fee Rates for Fiscal Year 2014

Posted 01 August 2013 | By Alexander Gaffney, RAC

The US Food and Drug Administration (FDA) has just published the user fee rates set to go into effect for the coming 2014 fiscal year (FY), including those for pharmaceuticals, biosimilars, facilities, master files, generic drugs and medical devices.

Background

Since the early 1990s, FDA has become increasingly reliant upon user fees to fund its operations. Whereas before the agency relied almost entirely on federal funding to conduct its operations, now nearly all industries regulated by FDA pay the agency under various user fee agreements, and do so willingly.

Most industries also negotiate these fees directly with the agency, resulting in user fee legislation that is submitted by FDA to Congress, albeit in draft form. Many industries are also broadly in favor of the fees, as they generate a greater return on investment by permitting a more expeditious regulatory process. For example, under the Prescription Drug User Fee Act (PDUFA), now in its fifth iteration, each new drug application submitted to FDA is submitted along with a substantial user fee. This permits FDA to hire more staff, allowing it to review products more quickly, thereby allowing the company to bring the product to market more quickly as well. 

Since the 1992 passage of PDUFA, Congress has passed many other user fee acts covering medical devices, generic drugs, veterinary drugs, biosimilars and food products, as well as related inspection and registration activities.

User Fees at a Glance

The agency is now out with several documents outlining the fees expected to be paid members of the life science industry for covered activities during FY 2014.

Activity

Standard Fee

Small Business Fee

Prescription Drug User Fee Act (PDUFA)

New Drug Application (With Clinical Data)

$2,169,100

New Drug Application (Without Clinical Data)

$1,084,550

New Drug Application Supplement With Clinical Data

$1,084,550

NDA Establishment

$554,600

Annual Product Registration

$104,060

Medical Device User Fee Act (MDUFA)

Premarket Application

$258,520

$64,630

Product Development Protocol

$258,520

$64,630

Biologics Licensing Application

$258,520

$64,630

Premarket Report

$258,520

$64,630

Panel-Track Supplement

$193,890

$48,473

180-Day Supplement

$38,778

$9,695

Real-Time Supplement

$18,096

$4,524

510(k) Premarket Notification Submission

$5,170

$2,585

30-Day Notice

$4,136

$2,068

513(g) Request for Classification Information

$3,490

$1,745

Annual Fee for Class III Device

$9,048

$2,262

Annual Establishment Registration

$3,313

$3,313

Generic Drug User Fee Act (GDUFA)

Abbreviated New Drug Application

$63,860

Prior Approval Supplement

$31,930

Drug Master File

$31,460

Foreign Facility Fee Differential

$15,000

Finished Dosage Form Facility (Domestic)

$220,152

Finished Dosage Form Facility (Foreign)

$235,152

Active Pharmaceutical Ingredient Facility (Domestic)

$34,515

Active Pharmaceutical Ingredient Facility (Foreign)

$49,515

Biosimilar User Fee Act (BsUFA)

Biosimilar Application (Requiring Clinical Data)

$2,169,100

Biosimilar Application (Not Requiring Clinical Data)

$1,084,550

Biosimilar Supplement (Requiring Clinical Data)

$1,084,550

Biological Product Development (Initial)

$216,910

Biological Product Development (Annual)

$216,910

Biological Product Development (Reactivation)

$433,820

Establishment Fee

$554,600

Product Fee

$104,060

Animal Drug User Fee Act (ADUFA)

Animal Drug Application (New)

$396,600

Animal Drug Application (Supplement)

$198,300

Animal Drug Product Fee

$9,075

Animal Drug Establishment Fee

$105,800

Animal Drug Sponsor Fee

$101,150

Animal Generic Drug User Fee Act (AGDUFA)

Abbreviated Application Fee for Generic New Animal Drug except those subject to the criteria in section 512(d)(4)

$177,900

Abbreviated Application Fee for Generic New Animal Drug subject to the criteria in section 512(d)(4)

$88,950

Generic New Animal Drug Product Fee

$8,035

Sponsor Fee (Seven or More Approved Products)

$72,800

Sponsor Fee (Three or More Approved Products)

$54,600

Sponsor Fee (One or Fewer Approved Products)

$36,400




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