Information Collection

Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for Orphan Medicinal Product Designation (Form FDA 3671)

IC 182669 under ICR 201105-0910-005 · OMB 0910-0167.

⚠️ Notice: This information collection may be referencing outdated material.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

Documents and Forms

Documents and forms in this information collection
Document Name	Document Type
Form FDA 3671 Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for 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

IC Title:

Orphan Drugs; Common European Medicines Agency/Food and Drug Administration Application Form for Orphan Medicinal Product Designation (Form FDA 3671)

Agency IC Tracking Number:

Is this a Common Form? No

IC Status: Removed

Obligation to Respond: Mandatory

CFR Citation:

Information Collection Instruments:

table that charts list of 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 %

table that charts list of burden
	Program Change Due to Agency Discretion	Previously Approved
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

table that charts IC Documents
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.