Common European Medicines Agency/Food and Drug Administration Application Form

Orphan Products Development; Common European Medicines Agency/FDA Form for Orphan Medicinal Product Designation and FDA Orphan Drug Designation Request Form

⚠️ Notice: This information collection may be referencing outdated material. More recent filings for OMB 0910-0167 can be found here:

Documents and Forms

Document Name Document Type
Form Form 3671 Common European Medicines Agency/Food and Drug Administration Application Form Form and Instruction
Form 3671 Common EMEA/FDA Application for Orphan Medicinal Product 0167_Form 3671.pdf Form and Instruction
Form 4035 FDA Application for Orphan Medicinal Product Designation 0167_FDA-4035.pdf Form and Instruction

Information Collection (IC) Details

IC Title:	Common European Medicines Agency/Food and Drug Administration Application Form	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation:

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	Form 3671	Common EMEA/FDA Application for Orphan Medicinal Product Designation	0167_Form 3671.pdf		Yes	Yes	Fillable Fileable Signable
Form and Instruction	Form 4035	FDA Application for Orphan Medicinal Product Designation	0167_FDA-4035.pdf		Yes	Yes	Fillable Fileable Signable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 496	Number of Respondents for Small Entity: 0

Affected Public: Private Sector	Private Sector: Businesses or other for-profits

Percentage of Respondents Reporting Electronically: 0 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	620	470	150
Annual IC Time Burden (Hours)	19,840	13,090	6,750
Annual IC Cost Burden (Dollars)	0	0	0

Documents for IC

Title	Document	Date Uploaded
No associated records found

Blank fields in records indicate information that was not collected or not collected electronically prior to July 2006.