Common European Medicines Agency/Food and Drug Administration Application Form

Orphan Drugs

⚠️ Notice: This information collection may be referencing outdated material.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 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
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: Removed

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 %

	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	-620	620
Annual IC Time Burden (Hours)	-19,840	19,840
Annual IC Cost Burden (Dollars)	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.