Information Collection

Common European Medicines Agency/Food and Drug Administration Application Form

IC 212826 under ICR 202011-0910-012 · 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⚠️ Notice: This information collection may be referencing outdated material.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 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

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:

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	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 %

table that charts list of burden
	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

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.