Orphan Drug: Content and format of a request for designation; verification of status; amendment to designation

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

⚠️ Notice: This information collection may be referencing outdated material.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 FDA3671 Orphan Drug: Content and format of a request for designation; verification of status; amendment to designation Form and Instruction
FDA3671 Common EMEA/FDA Application for Orphan Medicinal Product FDA 3671.pdf Form and Instruction

Information Collection (IC) Details

IC Title:	Orphan Drug: Content and format of a request for designation; verification of status; amendment to designation	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 316.20 21 CFR 316.21 21 CFR 316.26

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Form and Instruction	FDA3671	Common EMEA/FDA Application for Orphan Medicinal Product Designation	FDA 3671.pdf		Yes	Yes	Fillable Fileable Signable

Line of Business: Health

Subfunction: Immunization Management

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 214	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 40 %

	Approved	Change Due to Adjustment in Agency Estimate	Previously Approved
Annual Number of Responses for this IC	428	86	342
Annual IC Time Burden (Hours)	64,200	19,740	44,460
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.