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  • Fda Form 3397

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SUPPORTING STATEMENT for User Fee Cover Sheet - Form FDA 3397 OMB # 0910-0297 JUSTIFICATION 1. Need and Legal Basis The Food and Drug Administration (FDA) is requesting an extension of Office of Management.

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The FDA Electronic Submissions Gateway (ESG) is the central transmission point for sending information electronically to FDA. The ESG does not open or review submissions. It receives submissions, acknowledges receipt, routes them to the proper FDA center or office, and notifies that center or office of delivery.

The eCTD is the standard format for submitting applications, amendments, supplements, and reports to FDA's Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER).

I. Background Generic drug fee categoryFees rates for FY 2023GDUFA ProgramLarge size operation generic drug applicant1,620,556Medium size operation generic drug applicant648,222Small business operation generic drug applicant162,05611 more rows • Oct 12, 2022

Form FDA 3397, the PDUFA user fee cover sheet, is designed to provide the minimum necessary information to determine whether a fee is required for review of an application, to determine the amount of the fee required, and to help FDA track payments.

Electronic submissions must use the version of eCTD currently supported by FDA, which is specified in the FDA Data Standards Catalog on the Study Data Standards Resources page.

The user fees provide the FDA with supplemental resources for reviewing product applications based on the scientific and clinical evidence, and conducting related activities.

Electronic Common Technical Document -eCTD ICH recommended CTD folder structure. XML backbone containing metadata such as document id, document version, hyperlinks, file title, and leaf operation. Regional module XML backbone, files, and folders (such as application form and cover letter)

Electronic submissions must include only FDA fillable forms (e.g., 1571, 356h) and electronic signatures to enable automated processing of the submission. The most current FDA forms are available at .fda.gov/AboutFDA/ ReportsManualsForms/Forms. Scanned images of FDA forms will not be accepted.

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© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232
Form Packages
Adoption
Bankruptcy
Contractors
Divorce
Home Sales
Employment
Identity Theft
Incorporation
Landlord Tenant
Living Trust
Name Change
Personal Planning
Small Business
Wills & Estates
Packages A-Z
Form Categories
Affidavits
Bankruptcy
Bill of Sale
Corporate - LLC
Divorce
Employment
Identity Theft
Internet Technology
Landlord Tenant
Living Wills
Name Change
Power of Attorney
Real Estate
Small Estates
Wills
All Forms
Forms A-Z
Form Library
Customer Service
Terms of Service
DMCA Policy
About Us
Blog
Affiliates
Contact Us
Privacy Notice
Delete My Account
Site Map
Industries
Forms in Spanish
Localized Forms
State-specific Forms
Forms Kit
Legal Guides
Real Estate Handbook
All Guides
Prepared for You
Notarize
Incorporation services
Our Customers
For Consumers
For Small Business
For Attorneys
Our Sites
US Legal Forms
USLegal
FormsPass
pdfFiller
signNow
airSlate workflows
DocHub
Instapage
Social Media
Call us now toll free:
1-877-389-0141
As seen in:
  • USA Today logo picture
  • CBC News logo picture
  • LA Times logo picture
  • The Washington Post logo picture
  • AP logo picture
  • Forbes logo picture
© Copyright 1997-2025
airSlate Legal Forms, Inc.
3720 Flowood Dr, Flowood, Mississippi 39232