Assessing User Fees Under the Generic Drug User Fee Amendments of 2017 Guidance for Industry

Description

This guidance provides stakeholders information regarding FDA’s implementation of the Generic Drug User Fee Amendments of 2017 (GDUFA II) under Title III of the FDA Reauthorization Act of 2017. Because GDUFA II created changes to the user fee program, this guidance serves to provide an explanation about the new fee structure and types of fees for which entities are responsible.

Key Topics

Terms and concepts identified from this document

Scope & Applicability

Product Classes

3

Finished dosage form

Manufacturing, processing, or testing of the finished dosage form.

FDF

Finished Dosage Form manufacturer facility

Positron emission tomography drug

Drug exhibiting spontaneous disintegration of unstable nuclei; Applications for PET drugs are exempt from ANDA filing fees.; PET drug manufacturers and fee exemptions

Stakeholders

10

Contract Manufacturing Organization

An FDF manufacturer facility not identified in an approved ANDA held by the owner

FDA forms manager

Contact person for assistance with accessing FDA forms.

ANDA applicant

Entity that has submitted an ANDA to the FDA; Entity requesting meetings with FDA; Entity seeking a post-submission meeting; party responsible for reviewing minutes and notifying FDA of disagreements

Repackagers

Entities subject to facility fee considerations

Packagers

Entities subject to facility fee considerations

Contract Manufacturing Organizations

Facility fee requirements for CMOs; CMOs qualifying for reduced facility fees

Facility Owner

The person or entity that incurs the facility fee.

PET Manufacturers

Positron Emission Tomography drug manufacturers

Contract manufacturing organization facility

Manufacturing facility of a finished dosage form not identified in an approved ANDA held by the owner

Affiliate

An entity whose sales must be included in the calculation if it is related to the facility.; Facility that controls, is controlled by, or is under common control with another facility

Regulatory Context

Regulatory Activities

8

Abbreviated New Drug Application

ANDA submission containing a waiver request

Type II API DMF

Drug Master File for active pharmaceutical ingredients

Drug Master File

Alternatively, a Drug Master File (DMF) may be referenced for this information.

GDUFA III

second reauthorization of the Generic Drug User Fee Amendments

PDUFA

Prescription Drug User Fee Act products

BsUFA

Biosimilar User Fee Act products

ANDA

Abbreviated New Drug Application

Prior Approval Supplement

Major changes requiring FDA approval before implementation

Document Types

7

Type II active pharmaceutical ingredient drug master file

Submission of information to support approval of a generic drug submission; Deemed submitted on the calendar day electronic submission arrives

Articles of Incorporation

Required documentation for size determination

GDUFA cover sheet

Electronic document used to track user fee payments

Post-approval supplement

Submitted to remove a manufacturing facility from an ANDA

GDUFA III commitment letter

GDUFA Reauthorization Performance Goals and Program Enhancements Fiscal Years 2023-2027.; FDA will review the criteria under the GDUFA III commitment letter for granting a meeting request

Type II Drug Master Files – Available for Reference List

List of DMFs that have passed completeness assessment

Orange Book

Approved Drug Products With Therapeutic Equivalence Evaluations

Attributes

6

Foreign-Facility Fee Differential

Higher fee rate for facilities located outside the United States; $15,000 higher than the amount of the fee for a domestic facility

facility fee

Annual fee for generic drug facilities; Facility user fee cover sheet

backlog fee

Fee for original ANDAs pending as of a certain date; GDUFA Backlog Arrears List

GDUFA program fee

Annual fee based on the number of approved applications

CMO facility fee

Reduced facility fee of 24 percent of the FDF facility fee

Fiscal year

Begins October 1 and ends September 30

Technical Details

Substances

3

Atypical APIs

Specific category of active pharmaceutical ingredients

API

Active Pharmaceutical Ingredient

Active pharmaceutical ingredient

Substance intended for incorporation into a finished drug product

Processes

3

Manufacturing

Information contained in MFs; Processes described within a Master File.

Testing

Laboratory analysis to determine HPHC quantities

Aseptic Processing

implied manufacturing process under QS regulation

Standards & References

External Standards

1

45 CFR 30.18

Interest and penalty on delinquent debt

Related CFR Sections (6)

21CFR10.75§ 10.75 Internal agency review of decisions.
(a) A decision of an FDA employee, other than the Commissioner, on a matter, is subject to review by the employee's supervisor under the following circumstances:Read full regulation →
21CFR314.101§ 314.101 Filing an NDA and receiving an ANDA.
(a) Filing an NDA.Read full regulation →
21CFR314.81§ 314.81 Other postmarketing reports.
(a) Applicability. Each applicant shall make the reports for each of its approved applications and abbreviated applications required under this section and section 505(k) of the act.Read full regulation →
21CFR314.70§ 314.70 Supplements and other changes to an approved NDA.
(a) Changes to an approved NDA.Read full regulation →
21CFR314.94§ 314.94 Content and format of an ANDA.
ANDAs are required to be submitted in the form and contain the information required under this section. Three copies of the ANDA are required, an archival copy, a review copy, and a field copy. FDA will maintain guidance documents on the format and content of ANDAs to assist applicants in their prepRead full regulation →
21CFR314.95§ 314.95 Notice of certification of invalidity, unenforceability, or noninfringement of a patent.
(a) Notice of certification. For each patent that claims the listed drug or that claims a use for such listed drug for which the applicant is seeking approval and for which the applicant submits a paragraph IV certification, the applicant must send notice of such certification by registered or certiRead full regulation →

Enforcement Impact

Deficiencies cited in Warning Letters referencing the same regulations

False or misleading risk presentation

4

Failure to submit under Form FDA-2253

3

Failure to submit promotional materials

2

Omission of material facts

2

False or misleading claims about efficacy and risks

1

False or misleading promotional communication

1

Failure to submit promotional materials at time of initial dissemination

1

False or Misleading Risk Presentation

1

Omission of Material Facts

1

Failure to Submit Under Form FDA-2253

1