PDUFA Cover Sheet Workspace

Step 1 of 8

Confirm scope and timing

Start with the FDA receipt date and regulatory pathway. These answers determine whether Form FDA 3397 applies and which fiscal-year rates are used.

PDUFA-R01

Planned FDA receipt date

Use the date FDA is expected to receive the complete application. The federal fiscal year runs October 1 through September 30.

FDA review center

How do I obtain this?

Use the center identified in FDA correspondence for the product or the center that manages the related IND. Confirm uncertain assignments with FDA.

Regulatory pathway

PDUFA Form FDA 3397 is for 505(b) NDAs and 351(a) BLAs, not ANDAs or 351(k) biosimilar applications.

Submission event

Why this matters

A resubmission after Refuse-to-File or withdrawal before filing is charged the applicable full or half fee again unless an FDA-granted waiver or reduction applies. A separate statutory exception can apply to a same-product resubmission that had been accepted for filing.

Does a statutory or program exclusion apply?

View excluded application categories

The statutory definition excludes supplements, specified blood and allergenic products, in vitro diagnostic biologics, certain older large-volume parenterals, biological products for further manufacturing use only, and noncommercial State or Federal submissions. ANDAs, 351(k) biosimilar applications, and annual program fees use different processes.

Detected fee schedule Not determined

Clinical data - No clinical data - PRV -

Advanced: manually maintained fee rates

Use only when the planned submission date is outside the built-in FY 2025-FY 2027 schedules or FDA has published a corrected rate. Record the official source in the notes field.

Use manual ratesManual values override the built-in schedule and create a review warning.

Full fee (USD)

Half fee (USD)

Voucher fee (USD)

Official source or change-control note

Step 2 of 8

Applicant and contacts

Enter the legal applicant and the person FDA may contact about the cover sheet or payment.

Applicant legal entity

Legal applicant name

How do I obtain this?

Use the exact legal applicant name used in the NDA/BLA and FDA establishment or application records, not an informal business name.

Address line 1

Address line 2

City

State / province / region

Postal code

Country

EIN / taxpayer ID internal export

Optional in this preparation tool. Confirm handling of tax identifiers under your privacy policy.

D-U-N-S / organization reference optional

Use the identifier maintained in your FDA user-fee account or master data, if applicable.

Authorized representative

Contact name

Title

Telephone

Billing contact Same as authorized representativeClear this box when invoices or payment questions should go to another contact.

Step 3 of 8

Application and product

Use product names and identifiers exactly as they appear in regulatory records.

Established / proper name

How do I obtain this?

Use the established name for a drug or the proper name for a biological product from the application cover letter, labeling, or FDA correspondence.

Proprietary / trade name if available

NDA/BLA number

How do I obtain this?

Use the six-digit NDA number or BLA submission tracking number assigned by FDA. Preserve leading zeroes. Confirm against FDA correspondence and the application submission plan.

Sponsor submission reference optional

A sponsor-controlled ID used for reconciliation and Oracle transaction flexfields.

Proposed indication / use

0/750 characters

Step 4 of 8

Clinical-data fee determination

The key question is whether safety or effectiveness clinical data other than bioavailability or bioequivalence studies are required for approval.

PDUFA-R02

Are covered clinical data required for approval?

Answer based on the data FDA requires to approve this application, including data incorporated by reference.

Yes - full application feeSafety or effectiveness clinical data other than BA/BE are required. No - one-half application feeNo such clinical data are required. BA/BE studies alone do not make the application a full-fee application. Not yet determinedThe form will remain not ready until this is resolved.

Decision guide

New pivotal safety or efficacy study requiredFull fee

Required study is supplied only by cross-referenceFull fee

Only BA/BE studies are requiredHalf fee

No safety/effectiveness clinical data requiredHalf fee

Step 5 of 8

Exception, exemption, waiver, or reduction

Select one fee-relief basis and enter evidence. The calculator applies relief only after all required criteria are met.

Claimed fee treatment

Step 6 of 8

Priority review voucher

A redeemed voucher adds a separate fee. It can be used for a 505(b)(1) NDA or 351(a) BLA and requires advance notice.

PDUFA-R09

Voucher use

Step 7 of 8

FDA payment references and Oracle AR mapping

FDA references support reconciliation. Oracle fields create an AutoInvoice-style staging CSV that must be mapped to your configured EBS transaction source.

FDA payment references

Official FDA user fee payment ID after FDA submission

How do I obtain this?

Submit the official online cover sheet in FDA's user-fee system. FDA generates an identifier beginning with “PD.” Do not invent this value.

FDA invoice number when issued

Planned payment method

Payment confirmation / bank reference

Payment date

FDA no longer accepts paper-based payments. Use the official FDA payment portal or wire instructions and include the FDA payment ID and application number as directed.

Oracle E-Business Suite Receivables - AutoInvoice staging profile

Configuration boundary: AutoInvoice-required values vary by imported transaction source, grouping rules, flexfield setup, customer master data, ledger, and operating unit. This export uses common RA_INTERFACE_LINES_ALL-style column names and does not write to Oracle.

Batch source name

Transaction type name

Line transaction flexfield context

Bill-to customer reference

Match HZ_CUST_ACCOUNTS.ORIG_SYSTEM_REFERENCE for your configured source.

Bill-to address reference

Payment term name

GL date

Confirm the date is in an open or future Oracle GL period.

Operating unit / org ID site-specific

Ledger / set of books ID site-specific

Purchase order / authorization

Revenue account code combination if loaded separately

Oracle comments

Step 8 of 8

Review, certify, and export

Resolve blocking errors, review warnings, and generate preparation artifacts. Then recreate and submit the official cover sheet in FDA's system.

Validation

Not ready

Fee determination

Application record

Integration record

Authorized preparation certification

Authorized representative name

Title

Review date

I reviewed the entered facts and supporting records.The fee result depends on the accuracy of the regulatory and financial facts entered. I understand this is not an FDA submission or invoice.The official FDA system must be used to submit Form FDA 3397 and obtain the official payment ID.

Outputs

Complete the required fields to enable outputs.

Import draft JSON

Required operational next step

Re-enter or verify the data in the official FDA cover-sheet system, submit it there, capture the generated PD... payment ID, and use the FDA payment portal.

Open FDA system

PDUFA Cover Sheet

Confirm scope and timing

Applicant and contacts

Application and product

Clinical-data fee determination

Decision guide

Exception, exemption, waiver, or reduction

Previously filed application exception

Orphan-designated drug exception

Skin-test diagnostic exception

FDA-granted waiver or reduction

Other FDA-confirmed fee determination

Priority review voucher

FDA payment references and Oracle AR mapping

Review, certify, and export

Validation

Fee determination

Application record

Integration record

Outputs

Rules, data logic, and official sources

Implemented rule catalog

Official and primary sources

Oracle integration boundary