Orphan Drug Products; Common EMEA/FDA Application Form from Orphan Medicinal Product Designation (form FDA 3671)

Orphan Drug Products

⚠️ Notice: This information collection may be referencing outdated material.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 FDA 3671 Orphan Drug Products; Common EMEA/FDA Application Form from Orphan Medicinal Product Designation (form FDA 3671) Form and Instruction
FDA 3671 COMMON EMEA/FDA APPLICATION FORM FOR ORPHAN MEDICINAL PR Final version of Common EMEA-FDA Application Form for Orphan Medicinal Product designationFINAL FORM.doc Form and Instruction

Information Collection (IC) Details

IC Title:	Orphan Drug Products; Common EMEA/FDA Application Form from Orphan Medicinal Product Designation (form FDA 3671)	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: New

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	FDA 3671	COMMON EMEA/FDA APPLICATION FORM FOR ORPHAN MEDICINAL PRODUCT DESIGNATION	Final version of Common EMEA-FDA Application Form for Orphan Medicinal Product designationFINAL FORM.doc		No	No	Paper Only

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 40	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	Program Change Due to Agency Discretion
Annual Number of Responses for this IC	40	40
Annual IC Time Burden (Hours)	1,280	1,280
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.