Information Collection

Common European Medicines Agency/Food and Drug Administration Application Form

IC 212826 under ICR 201408-0910-001 · 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⚠️ Notice: This information collection may be referencing outdated material.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

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 FDA-3671.rtf Form and Instruction

Information Collection (IC) Details

View Information Collection (IC)

IC Title:	Common European Medicines Agency/Food and Drug Administration Application Form	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	Form 3671	Common EMEA/FDA Application for Orphan Medicinal Product Designation	FDA-3671.rtf		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: 50	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	150	150
Annual IC Time Burden (Hours)	6,750	6,750
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.