Orphan Drug Requirements

Orphan Drugs

Documents and Forms

Document Name Document Type
0167 Guidance-Meetings with OPD.pdf Other-Guidance
FDA 4035 FDA Orphan Drug Designation Request Form 0167 FDA-4035.pdf Form and Instruction

Information Collection (IC) Details

IC Title:	Orphan Drug Requirements	Agency IC Tracking Number:

Is this a Common Form? No		IC Status: Modified

Obligation to Respond: Mandatory

CFR Citation: 21 CFR 316

Information Collection Instruments:

Document Type	Form No.	Form Name	Instrument File	URL	Available Electronically?	Can Be Submitted Electronically?	Electronic Capability
Other-Guidance			0167 Guidance-Meetings with OPD.pdf		Yes	Yes	Fillable Fileable
Form and Instruction	FDA 4035	FDA Orphan Drug Designation Request Form	0167 FDA-4035.pdf		Yes	Yes	Fillable Fileable

Line of Business: Health

Subfunction: Consumer Health and Safety

Privacy Act System of Records
Title:	FR Citation:

Number of Respondents: 2,039	Number of Respondents for Small Entity: 0

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

Percentage of Respondents Reporting Electronically: 100 %

	Requested	Previously Approved
Annual Number of Responses for this IC	5,613	5,613
Annual IC Time Burden (Hours)	174,289	174,289
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.